Draft Guidance for Industry on Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment; Availability, 11963-11964 [E9-6145]
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11963
Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR REGULATORS1
No. of
Recordkeepers
Types of Records
Voluntary Food Safety Management
System Evaluation (includes validation, verification, and completion of verification inspection
checklist)
Annual Frequency
of Recordkeeping
50,000
Total Annual
Records
1
Hours per
Recordkeeper
50,000
Total Hours
16
Total Annual Burden for Regulators
1 There
800,000
are no capital costs or operating and maintenance costs associated with this collection of information.
It is difficult to predict the number of
State, local, and tribal regulatory
jurisdictions that will use the
Regulator’s Manual. But, FDA
anticipates that retail and foodservice
establishments which voluntarily
develop and implement a food safety
management system based on the
Operator’s Manual will request their
regulatory authorities to conduct an
evaluation of their system. The
estimates in table 2 of this document for
the annual burden to State, local, and
tribal regulators that follow the
recommendations in the Regulator’s
Manual were calculated based on the
usual time needed for one person to
evaluate a voluntarily-implemented
food safety management system and
record the findings. The number of
times an inspector may be asked by an
operator to evaluate a voluntarilyimplemented system is not expected to
exceed once per year.
Dated: March 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–6168 Filed 3–19–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0136]
Draft Guidance for Industry on
Community-Acquired Bacterial
Pneumonia: Developing Drugs for
Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
800,000
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Community-Acquired
Bacterial Pneumonia: Developing Drugs
for Treatment.’’ This draft guidance
informs industry of FDA’s current
VerDate Nov<24>2008
17:07 Mar 19, 2009
Jkt 217001
thinking regarding the overall
development program and clinical trial
designs for drugs to support an
indication for treatment of communityacquired bacterial pneumonia (CABP).
This draft guidance does not address the
development of drugs for other purposes
or populations, such as treatment of
patients with hospital-acquired
pneumonia or ventilator-associated
pneumonia. This draft guidance revises
the draft guidance for industry entitled
‘‘Community-Acquired PneumoniaDeveloping Antimicrobial Drugs for
Treatment’’ published July 1998.
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 June 18, 2009.
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:
Sumathi Nambiar, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6232,
Silver Spring, MD 20993–0002,
301–796–1400; or
Edward Cox, Center for Drug
Evaluation and Research, 10903
New Hampshire Ave., Bldg. 22, rm.
6212, Silver Spring, MD 20993–
0002, 301–796–1300.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Community-Acquired Bacterial
Pneumonia: Developing Drugs for
Treatment.’’ Since FDA published the
draft guidance on the development of
antimicrobial drugs for the treatment of
community-acquired pneumonia in
1998, there have been public
discussions regarding clinical trial
designs to study CABP, including an
FDA–Infectious Disease Society of
America (IDSA) workshop and a
meeting of the Anti-Infective Drugs
Advisory Committee. These discussions
have focused on clinical trial designs for
CABP and other important issues such
as the following:
• Noninferiority versus superiority
design
• Justification of an appropriate
noninferiority margin
• Classification of severity of illness
• Classification of CABP based on
hospitalization (inpatient versus
outpatient)
• Enrollment criteria
• Application of appropriate
diagnostic criteria, including
microbiologic diagnosis
• Use of appropriate definitions of
clinical outcomes, including mortality
• Timing of outcome assessments
• Use of prior antibacterial drugs
Important changes from the 1998 draft
guidance that are based on these
discussions have been incorporated into
this revised draft guidance.
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 the development of antibacterial
drugs for CABP including appropriate
clinical trial designs to evaluate drugs
for the treatment of CABP. 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
E:\FR\FM\20MRN1.SGM
20MRN1
11964
Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Notices
satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of
1995
This draft 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
part 312 have been approved under
OMB control no. 0910–0014; the
collections of information in 21 CFR
part 314 have been approved under
OMB control no. 0910–0001; and the
collections of information referred to in
the guidance ‘‘Establishment and
Operation of Clinical Trial Data
Monitoring Committees’’ have been
approved under OMB control no. 0910–
0581.
III. 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
www.regulations.gov.
Transportation Security Administration
New Agency Information Collection
Activity Under OMB Review: Security
Program Training Feedback for
Hazardous Materials Motor Carriers &
Shippers
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
Jkt 217001
Dated: March 10, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–5995 Filed 3–19–09; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
BILLING CODE 4160–01–S
17:07 Mar 19, 2009
Name of Committee: National Institute of
Nursing Research, Special Emphasis Panel,
NINR Loan Repayment Program Review
(L30/L40).
Date: April 16, 2009.
Time: 10 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Yujing Liu, PhD, MD,
Chief, Office of Review, Division of
Extramural Activities, National Institute of
Nursing Research, National Institutes of
Health, 6701 Democracy Blvd., Ste 710,
Bethesda, MD 20892. (301) 451–5152.
yujing_liu@nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
BILLING CODE 4140–01–M
Dated: March 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–6145 Filed 3–19–09; 8:45 am]
VerDate Nov<24>2008
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
AGENCY: Transportation Security
Administration, DHS.
ACTION: 30 Day Notice.
SUMMARY: This notice announces that
the Transportation Security
Administration (TSA) has forwarded the
new Information Collection Request
(ICR) abstracted below to the Office of
Management and Budget (OMB) for
review and approval under the
Paperwork Reduction Act. The ICR
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
describes the nature of the information
collection and its expected burden. TSA
published a Federal Register notice,
with a 60-day comment period soliciting
comments, of the following collection of
information on November 20, 2008, 73
FR 70359. TSA will provide a voluntary
security-related training course to the
Hazardous Materials (Hazmat) motor
carrier and shipper industry, to include
an evaluation for respondents to
complete. TSA will use this data to
measure the program’s effectiveness at
achieving its goal of heightened security
awareness levels throughout the hazmat
motor carrier and shipper industry.
DATES: Send your comments by April
20, 2009. A comment to OMB is most
effective if OMB receives it within 30
days of publication.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to Desk Officer, Department of
Homeland Security/TSA, and sent via
electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–6974.
FOR FURTHER INFORMATION CONTACT:
Ginger LeMay, Office of Information
Technology, TSA–11, Transportation
Security Administration, 601 South
12th Street, Arlington, VA 20598–6011;
telephone (571) 227–3616; e-mail
ginger.lemay@dhs.gov.
SUPPLEMENTARY INFORMATION:
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number. The ICR documentation is
available at https://www.reginfo.gov.
Therefore, in preparation for OMB
review and approval of the following
information collection, TSA is soliciting
comments to—
(1) Evaluate whether the proposed
information requirement is necessary for
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including using
appropriate automated, electronic,
mechanical, or other technological
E:\FR\FM\20MRN1.SGM
20MRN1
]]>Agencies
[Federal Register Volume 74, Number 53 (Friday, March 20, 2009)]
[Notices]
[Pages 11963-11964]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6145]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0136]
Draft Guidance for Industry on Community-Acquired Bacterial
Pneumonia: 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 ``Community-
Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' This
draft guidance informs industry of FDA's current thinking regarding the
overall development program and clinical trial designs for drugs to
support an indication for treatment of community-acquired bacterial
pneumonia (CABP). This draft guidance does not address the development
of drugs for other purposes or populations, such as treatment of
patients with hospital-acquired pneumonia or ventilator-associated
pneumonia. This draft guidance revises the draft guidance for industry
entitled ``Community-Acquired Pneumonia-Developing Antimicrobial Drugs
for Treatment'' published July 1998.
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 June 18, 2009.
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:
Sumathi Nambiar, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6232,
Silver Spring, MD 20993-0002, 301-796-1400; or
Edward Cox, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 22, rm. 6212, Silver Spring, MD 20993-0002, 301-
796-1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Community-Acquired Bacterial Pneumonia: Developing Drugs for
Treatment.'' Since FDA published the draft guidance on the development
of antimicrobial drugs for the treatment of community-acquired
pneumonia in 1998, there have been public discussions regarding
clinical trial designs to study CABP, including an FDA-Infectious
Disease Society of America (IDSA) workshop and a meeting of the Anti-
Infective Drugs Advisory Committee. These discussions have focused on
clinical trial designs for CABP and other important issues such as the
following:
Noninferiority versus superiority design
Justification of an appropriate noninferiority margin
Classification of severity of illness
Classification of CABP based on hospitalization (inpatient
versus outpatient)
Enrollment criteria
Application of appropriate diagnostic criteria, including
microbiologic diagnosis
Use of appropriate definitions of clinical outcomes,
including mortality
Timing of outcome assessments
Use of prior antibacterial drugs
Important changes from the 1998 draft guidance that are based on
these discussions have been incorporated into this revised draft
guidance.
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 the
development of antibacterial drugs for CABP including appropriate
clinical trial designs to evaluate drugs for the treatment of CABP. 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
[[Page 11964]]
satisfies the requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This draft 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 part 312 have been
approved under OMB control no. 0910-0014; the collections of
information in 21 CFR part 314 have been approved under OMB control no.
0910-0001; and the collections of information referred to in the
guidance ``Establishment and Operation of Clinical Trial Data
Monitoring Committees'' have been approved under OMB control no. 0910-
0581.
III. 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.regulations.gov.
Dated: March 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6145 Filed 3-19-09; 8:45 am]
BILLING CODE 4160-01-S
