Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for Treatment; Availability, 13765-13766 [2010-6310]
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Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Notices
13765
GENERAL SERVICES
ADMINISTRATION
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
FOR FURTHER INFORMATION CONTACT: Mr.
Ernest Woodson, Procurement Analyst,
Contract Policy Branch, at telephone
(202) 501–3775 or via e-mail to
ernest.woodson@gsa.gov.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2010–D–0146]
A. Purpose
Draft Guidance for Industry on Irritable
Bowel Syndrome—Clinical Evaluation
of Products for Treatment; Availability
DEPARTMENT OF DEFENSE
[OMB Control No. 9000–00XX; Docket 2010–
0083, Sequence 17]
Submission for OMB Review; Use of
Project Labor Agreements for Federal
Construction Projects
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for public
comments regarding a new OMB
information clearance.
jlentini on DSKJ8SOYB1PROD with NOTICES
AGENCY:
SUMMARY: Under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35), the Regulatory
Secretariat will be submitting to the
Office of Management and Budget
(OMB) a request to review and approve
a new information collection
requirement regarding Use of Project
Labor Agreements for Federal
Construction Projects.
A request for public comments was
published in the Federal Register at 74
FR 33953, on July 14, 2009. No
comments were received.
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
DATES: Submit comments on or before
April 22, 2010.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to the GSA Desk Officer, OMB,
Room 10236, NEOB, Washington, DC
20503, and a copy to the Regulatory
Secretariat (MVCB), General Services
Administration, 1800 F Street, NW.,
Room 4041, Washington, DC 20405.
Please cite OMB Control No. 9000–
00XX, Use of Project Labor Agreements
for Federal Construction Projects, in all
correspondence.
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FAR 22.501 prescribes policies and
procedures to implement Executive
Order 13502, February 6, 2009, which
encourages Federal agencies to consider
the use of a project labor agreement
(PLA), as they may decide appropriate,
on large-scale construction projects,
where the total cost to the Government
is more than $25 million, in order to
promote economy and efficiency in
Federal procurement. A PLA is a prehire collective bargaining agreement
with one or more labor organizations
that establishes the terms and
conditions of employment for a specific
construction project. FAR 22.503(b)
provides that an agency may, if
appropriate, require that every
contractor and subcontractor engaged in
construction on the project agree, for
that project, to negotiate or become a
party to a project labor agreement with
one or more labor organizations if the
agency decides that the use of project
labor agreements will—
(1) Advance the Federal Government’s
interest in achieving economy and
efficiency in Federal procurement,
producing labor-management stability,
and ensuring compliance with laws and
regulations governing safety and health,
equal employment opportunity, labor
and employment standards, and other
matters; and,
(2) Be consistent with law.
B. Annual Reporting Burden
Respondents: 70.
Responses per Respondent: 1.
Annual Responses: 70.
Hours per Response: 1.
Total Burden Hours: 70.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCB), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 9000–
00XX, Use of Project Labor Agreements
for Federal Construction Projects, in all
correspondence.
Dated: March 18, 2010.
Al Matera,
Director, Acquisition Policy Division.
[FR Doc. 2010–6404 Filed 3–22–10; 8:45 am]
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Food and Drug Administration
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 ‘‘Irritable Bowel
Syndrome—Clinical Evaluation of
Products for Treatment.’’ This guidance
addresses the following three main
topics regarding irritable bowel
syndrome (IBS) sign and symptom
assessment for IBS with diarrhea (IBS–
D) and IBS with constipation (IBS–C):
The evolution of primary endpoints for
IBS clinical trials, interim
recommendations for IBS clinical trial
design and endpoints, and the future
development of patient-reported
outcome (PRO) instruments for use in
IBS clinical trials. This guidance is
intended to assist the pharmaceutical
industry and other investigators who are
conducting new product development
for the treatment of IBS.
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 May 24, 2010.
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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. 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 (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Ruyi
He, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
E:\FR\FM\23MRN1.SGM
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13766
Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Notices
Ave., Bldg. 22, rm. 5122, Silver Spring,
MD 20993–0002, 301–796–0910.
SUPPLEMENTARY INFORMATION:
jlentini on DSKJ8SOYB1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Irritable Bowel Syndrome—Clinical
Evaluation of Products for Treatment.’’
This guidance is intended to assist the
pharmaceutical industry and other
investigators who are conducting new
product development for the treatment
of IBS–D and IBS–C.
A content-valid PRO instrument that
measures the clinically important signs
and symptoms associated with each IBS
subtype is the ideal primary efficacy
assessment tool in clinical trials used to
support labeling claims. However, at
this time, an adequate instrument is not
available. We recognize that it will take
some time to develop adequate
instruments and that in the meantime
there is a great need to develop effective
therapies for patients with IBS.
Therefore, until the appropriate PRO
instruments have been developed, this
guidance recommends interim strategies
for IBS clinical trial design and
endpoints, and discusses the future
development of PRO instruments for use
in IBS clinical trials.
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 agency’s current thinking
on clinical evaluation of products for
the treatment of irritable bowel
syndrome. 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
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
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16:31 Mar 22, 2010
Jkt 220001
Guidances/default.htm or https://
www.regulations.gov.
Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6310 Filed 3–22–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Food and Drug Administration and
Process Analytical Technology for
Pharma Manufacturing: Food and Drug
Administration—Partnering With
Industry; Public Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug Administration
(FDA) is announcing a joint conference
with the University of Rhode Island
(URI) College of Pharmacy entitled
‘‘FDA and PAT for Pharma
Manufacturing: FDA—Partnering with
Industry.’’ This 2-day public conference
is cosponsored by FDA and the URI
College of Pharmacy. This public
conference is intended to disseminate
current and accurate information on
process analytical technology (PAT) to
the pharmaceutical industry and create
a venue for dialogue between PAT users
and FDA. The public conference will
feature FDA’s perspective on where
PAT will be applicable in the
manufacturing process and FDA’s
current thinking on how PAT will be
reviewed in new and abbreviated new
drug applications, amendments, or
supplements to an application.
Date and time: The public conference
will be held on May 11 and 12, 2010,
from 8 a.m. to 5 p.m.
Location: The public conference will
be held at the Hyatt Regency Bethesda,
One Bethesda Metro, Bethesda, MD
20814, 301–657–1234.
Contact Persons:
For information regarding the
conference and registration: Christi
Counts, Pharma Conference Inc., P.O.
Box 291386, Kerrville, TX, 78029–1386,
830–896–0027, FAX: 830–896–0029,
https://www.pharmaconference.com.
For information regarding this notice:
Chris Watts, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 4142, Silver Spring,
MD 20993–0002, 301–796–1625.
Registration: There is a registration
fee. The registration fee includes
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conference materials, continental
breakfast, breaks, and lunches. For
payment received by April 15, 2010, the
fee is $1,795. For payment received after
April 15, 2010, the fee is $1,995. The fee
for government employees is $750. The
following forms of payment will be
accepted: American Express, Visa,
Mastercard, and company checks. No
checks will be accepted on site. Early
registration is recommended because
seating is limited. There will be no
onsite registration. To register for the
public conference online, please visit
https://www.pharmaconference.com/
upcoming2010/beth_10.htm. To register
by mail, please send your name, title,
firm name, address, telephone and fax
numbers, e-mail, and credit card
information or a company check for the
fee to Pharma Conference Inc., P.O. Box
291386, Kerrville, TX, 78029–1386. To
register by overnight mail, the address is
Pharma Conference Inc., 819 Water St.,
suite 350, Kerrville, TX, 78028.
If you need special accommodations
due to a disability, please notify Pharma
Conference Inc., once you receive your
registration confirmation so these needs
can be passed on to the conference
venue.
Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6265 Filed 3–22–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0201] (formerly
Docket No. 2007D–0118)
Guidance for Industry on the Content
and Format of the Dosage and
Administration Section of Labeling for
Human Prescription Drug and
Biological Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Dosage and Administration
Section of Labeling for Human
Prescription Drug and Biological
Products—Content and Format.’’ This
guidance is one of a series of guidance
documents intended to assist applicants
in drafting prescription drug labeling in
which prescribing information is clear
and accessible and in complying with
the requirements in the final rule on the
content and format of labeling for
E:\FR\FM\23MRN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 55 (Tuesday, March 23, 2010)]
[Notices]
[Pages 13765-13766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6310]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0146]
Draft Guidance for Industry on Irritable Bowel Syndrome--Clinical
Evaluation of Products 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 ``Irritable
Bowel Syndrome--Clinical Evaluation of Products for Treatment.'' This
guidance addresses the following three main topics regarding irritable
bowel syndrome (IBS) sign and symptom assessment for IBS with diarrhea
(IBS-D) and IBS with constipation (IBS-C): The evolution of primary
endpoints for IBS clinical trials, interim recommendations for IBS
clinical trial design and endpoints, and the future development of
patient-reported outcome (PRO) instruments for use in IBS clinical
trials. This guidance is intended to assist the pharmaceutical industry
and other investigators who are conducting new product development for
the treatment of IBS.
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 May 24, 2010.
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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. 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 (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to https://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Ruyi He, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire
[[Page 13766]]
Ave., Bldg. 22, rm. 5122, Silver Spring, MD 20993-0002, 301-796-0910.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Products
for Treatment.'' This guidance is intended to assist the pharmaceutical
industry and other investigators who are conducting new product
development for the treatment of IBS-D and IBS-C.
A content-valid PRO instrument that measures the clinically
important signs and symptoms associated with each IBS subtype is the
ideal primary efficacy assessment tool in clinical trials used to
support labeling claims. However, at this time, an adequate instrument
is not available. We recognize that it will take some time to develop
adequate instruments and that in the meantime there is a great need to
develop effective therapies for patients with IBS. Therefore, until the
appropriate PRO instruments have been developed, this guidance
recommends interim strategies for IBS clinical trial design and
endpoints, and discusses the future development of PRO instruments for
use in IBS clinical trials.
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 agency's current thinking on clinical
evaluation of products for the treatment of irritable bowel syndrome.
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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6310 Filed 3-22-10; 8:45 am]
BILLING CODE 4160-01-S
