Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices; Correction, 43781 [2015-18043]

Download as PDF Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–2479] Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Gastroparesis: Clinical Evaluation of Drugs for Treatment.’’ This draft guidance is intended to provide FDA’s current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 21, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// www.regulations.gov.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: Ruyi He, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5122, Silver Spring, MD 20993–0002, 301–796–0910. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: clinical development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the clinical evaluation of drugs for the treatment of diabetic and idiopathic gastroparesis. 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. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that 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 parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. III. Comments Interested persons may submit either electronic comments regarding this document to http://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 http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: July 17, 2015. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0776] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices’’ that appeared in the Federal Register of June 12, 2015 (80 FR 33524). The document announced 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. The document inadvertently contained inaccurate information regarding communications with industry, including inaccurate contact information. This document corrects that error. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In the Federal Register of Friday, June 12, 2015, in FR Doc. 2015–14358, the following correction is made: On page 33524, in the third column, in the third full paragraph, delete the last sentence starting with ‘‘The trade organizations involved . . .’’ and the following contact information. SUPPLEMENTARY INFORMATION: [FR Doc. 2015–18023 Filed 7–22–15; 8:45 am] Dated: July 17, 2015. Leslie Kux, Associate Commissioner for Policy. BILLING CODE 4164–01–P [FR Doc. 2015–18043 Filed 7–22–15; 8:45 am] I. Background BILLING CODE 4164–01–P FDA is announcing the availability of a draft guidance for industry entitled ‘‘Gastroparesis: Clinical Evaluation of Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in the VerDate Sep<11>2014 18:39 Jul 22, 2015 Jkt 235001 43781 PO 00000 Frm 00077 Fmt 4703 Sfmt 9990 E:\FR\FM\23JYN1.SGM 23JYN1

Agencies

[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Page 43781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0776]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reclassification 
Petitions for Medical Devices; 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 ``Agency Information Collection Activities; Submission for 
Office of Management and Budget Review; Comment Request; 
Reclassification Petitions for Medical Devices'' that appeared in the 
Federal Register of June 12, 2015 (80 FR 33524). The document announced 
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. The document inadvertently 
contained inaccurate information regarding communications with 
industry, including inaccurate contact information. This document 
corrects that error.

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 the Federal Register of Friday, June 12, 
2015, in FR Doc. 2015-14358, the following correction is made:
    On page 33524, in the third column, in the third full paragraph, 
delete the last sentence starting with ``The trade organizations 
involved . . .'' and the following contact information.

    Dated: July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18043 Filed 7-22-15; 8:45 am]
 BILLING CODE 4164-01-P