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
<![CDATA[
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Drugs for Treatment; Draft Guidance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announcing the availability of a draft
guidance for industry entitled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 This draft
guidance is intended to provide FDA’s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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by September 21,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single copies of the draft guidance to the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access to the draft guidance document.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draft guidance to https://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: 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This draft guidance is being issued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The draft guidance, when finalized, will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 https://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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
