[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Page 60851]
[FR Doc No: 2014-23956]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0493]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Additional Criteria and Procedures
for Classifying Over-the-Counter Drugs as Generally Recognized as Safe
and Effective and Not Misbranded

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 ``Additional Criteria and Procedures
for Classifying Over-the-Counter Drugs as Generally Recognized as Safe
and Effective and Not Misbranded'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 25, 2014, the Agency submitted a
proposed collection of information entitled ``Additional Criteria and
Procedures for Classifying Over-the-Counter Drugs as Generally
Recognized as Safe and Effective and Not Misbranded'' 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 0910-0688. The approval expires on August 31, 2017. A
copy of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23956 Filed 10-7-14; 8:45 am]
BILLING CODE 4164-01-P


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63618
Federal Register/Vol. 72, No. 217 /Friday, November 9, 2007 /Notices
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, at 240ñ276ñ8932, at least 7 days
in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
http://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: November 2, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7ñ21979 Filed 11ñ8ñ07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0419]
Draft Guidance for Industry on Chronic
Obstructive Pulmonary Disease:
Developing Drugs for Treatment;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ëëChronic Obstructive
Pulmonary Disease: Developing Drugs
for Treatment.íí This guidance is
intended to assist the pharmaceutical
industry in designing a clinical
development program for new drugs for
the treatment of chronic obstructive
pulmonary disease (COPD). The
emphasis of this guidance is on the
assessment of efficacy of a new
molecular entity in phase 3 clinical
studies of COPD.
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
written or electronic comments on the
draft guidance by January 8, 2008.
ADDRESSES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFDñ
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one self-
addressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFAñ305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.fda.gov/dockets/ecomments or
http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION
section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Badrul A. Chowdhury, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 3316,
Silver Spring, MD 20993ñ0002, 301ñ
796
–2300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Chronic Obstructive Pulmonary
Disease: Developing Drugs for
Treatment.íí This guidance is intended
to assist the pharmaceutical industry in
designing a clinical development
program for new drugs for the treatment
of COPD. The emphasis of this guidance
is on the assessment of efficacy of a new
molecular entity in phase 3 clinical
studies of COPD.
There is pressing need to develop new
drugs for COPD because the global
prevalence of COPD is rising, the
disease is associated with significant
morbidity and mortality, and current
treatment options are limited. The
currently available drugs for COPD are
mostly for symptomatic treatment and
have not been conclusively shown to
alter the underlying inflammation or to
alter disease progression. The principles
of development applied to COPD drugs
have been generally derived from those
used to develop drugs for asthma, with
the primary focus aimed at
demonstrating improvements in airway
obstruction. With improved
understanding of the pathophysiology
and clinical manifestations of COPD,
and the awareness of the importance of
inflammation in COPD and how this
inflammation differs from that occurring
in asthma, this is an appropriate time to
define characteristics of specific drug
development programs for COPD.
This draft guidance is being issued
consistent with FDAís good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agencyís current thinking
on developing drugs for the treatment of
COPD. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES
) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/cder/guidance/
index.htm or http://www.fda.gov/
ohrms/dockets/default.htm.
Dated: November 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7ñ21985 Filed 11ñ8ñ07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Nurse
Education and Practice; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92ñ463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
Nurse Education and Practice (NACNEP).
Dates and Times: November 15, 2007, 9
a.m.ñ5 p.m.
November 16, 2007, 9 a.m.ñ4 p.m.
Place: Doubletree Executive Hotel and
Meeting Center, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
Status: The meeting will be open to the
public.
Agenda: Agency and Bureau
administrative updates will be provided. The
purpose of the meeting will be to examine
the issues facing nursing education in
relation to teaching and learning strategies,
the needs of employers and consumers for
high quality professional nursing care across
the lifespan and in a variety of settings, and
nursing curricula to prepare the nursing
student at the basic level (associate degree,
diploma, and baccalaureate degree) to
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