80 FR 43781 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 141 (July 23, 2015)

Page Range		43781-43781
FR Document		2015-18043

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.

Federal Register, Volume 80 Issue 141 (Thursday, July 23, 2015)

[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Page 43781]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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

Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015 / Notices 43781

DEPARTMENT OF HEALTH AND clinical development of drugs for the DEPARTMENT OF HEALTH AND
HUMAN SERVICES treatment of diabetic and idiopathic HUMAN SERVICES
gastroparesis.
Food and Drug Administration Food and Drug Administration
This draft guidance is being issued
[Docket No. FDA–2015–D–2479] consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). [Docket No. FDA–2011–N–0776]
Gastroparesis: Clinical Evaluation of The draft guidance, when finalized, will
Drugs for Treatment; Draft Guidance represent the current thinking of FDA Agency Information Collection
for Industry; Availability Activities; Submission for Office of
on the clinical evaluation of drugs for
the treatment of diabetic and idiopathic Management and Budget Review;
AGENCY: Food and Drug Administration,
gastroparesis. It does not establish any Comment Request; Reclassification
HHS.
rights for any person and is not binding Petitions for Medical Devices;
ACTION: Notice. Correction
on FDA or the public. You can use an
SUMMARY: The Food and Drug alternative approach if it satisfies the
Administration (FDA or Agency) is AGENCY: Food and Drug Administration,
requirements of the applicable statutes
announcing the availability of a draft HHS.
and regulations.
guidance for industry entitled ACTION: Notice; correction.
‘‘Gastroparesis: Clinical Evaluation of II. The Paperwork Reduction Act of
Drugs for Treatment.’’ This draft 1995 SUMMARY: The Food and Drug
guidance is intended to provide FDA’s Administration is correcting a notice
current thinking regarding clinical trial This guidance refers to previously
approved collections of information that entitled ‘‘Agency Information Collection
design and clinical endpoint
are subject to review by the Office of Activities; Submission for Office of
assessments to support development of
Management and Budget (OMB) under Management and Budget Review;
drugs for the treatment of diabetic and
the Paperwork Reduction Act of 1995 Comment Request; Reclassification
idiopathic gastroparesis.
(44 U.S.C. 3501–3520). The collections Petitions for Medical Devices’’ that
DATES: Although you can comment on
of information in 21 CFR parts 312 and appeared in the Federal Register of June
any guidance at any time (see 21 CFR
314 have been approved under OMB 12, 2015 (80 FR 33524). The document
10.115(g)(5)), to ensure that the Agency
control numbers 0910–0014 and 0910– announced that a proposed collection of
considers your comment on this draft
guidance before it begins work on the 0001, respectively. information has been submitted to the
final version of the guidance, submit Office of Management and Budget
III. Comments (OMB) for review and clearance under
either electronic or written comments
on the draft guidance by September 21, Interested persons may submit either the Paperwork Reduction Act of 1995.
2015. electronic comments regarding this The document inadvertently contained
ADDRESSES: Submit written requests for document to http://www.regulations.gov inaccurate information regarding
single copies of the draft guidance to the or written comments to the Division of communications with industry,
Division of Drug Information, Center for Dockets Management (see ADDRESSES). It including inaccurate contact
Drug Evaluation and Research, Food is only necessary to send one set of information. This document corrects
and Drug Administration, 10001 New comments. Identify comments with the that error.
Hampshire Ave., Hillandale Building, docket number found in brackets in the FOR FURTHER INFORMATION CONTACT: FDA
4th Floor, Silver Spring, MD 20993– heading of this document. Received PRA Staff, Office of Operations, Food
0002. Send one self-addressed adhesive comments may be seen in the Division and Drug Administration, 8455
label to assist that office in processing of Dockets Management between 9 a.m. Colesville Rd., COLE–14526, Silver
your requests. See the SUPPLEMENTARY and 4 p.m., Monday through Friday, and Spring, MD 20993–0002, PRAStaff@
INFORMATION section for electronic
will be posted to the docket at http:// fda.hhs.gov.
access to the draft guidance document. www.regulations.gov.
Submit electronic comments on the SUPPLEMENTARY INFORMATION: In the
draft guidance to http:// IV. Electronic Access Federal Register of Friday, June 12,
www.regulations.gov. Submit written 2015, in FR Doc. 2015–14358, the
comments to the Division of Dockets Persons with access to the Internet
following correction is made:
Management (HFA–305), Food and Drug may obtain the document at either
Administration, 5630 Fishers Lane, Rm. http://www.fda.gov/Drugs/Guidance On page 33524, in the third column,
1061, Rockville, MD 20852. ComplianceRegulatoryInformation/ in the third full paragraph, delete the
Guidances/default.htm or http:// last sentence starting with ‘‘The trade
FOR FURTHER INFORMATION CONTACT: Ruyi
He, Center for Drug Evaluation and www.regulations.gov. organizations involved . . .’’ and the
Research, Food and Drug following contact information.
Dated: July 17, 2015.
Administration, 10903 New Hampshire Leslie Kux, Dated: July 17, 2015.
Ave., Bldg. 22, Rm. 5122, Silver Spring, Leslie Kux,
Associate Commissioner for Policy.
MD 20993–0002, 301–796–0910. Associate Commissioner for Policy.
[FR Doc. 2015–18023 Filed 7–22–15; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES

SUPPLEMENTARY INFORMATION: [FR Doc. 2015–18043 Filed 7–22–15; 8:45 am]
BILLING CODE 4164–01–P
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

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Document Created: 2015-12-15 12:53:17
Document Modified: 2015-12-15 12:53:17

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; correction.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 43781

80 FR 43781 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 141 (July 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration