Draft Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability, 61358-61359 [E7-21332]
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Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
Under the
Federal Food, Drug, and Cosmetic Act
(section 409(b)(5) (21 U.S.C. 348(b)(5)),
notice is given that a food additive
petition (FAP No. 2256) has been filed
by Betty J. Pendleton, 768 Arbor Court,
Mobile, Alabama 36609, US agent for
Biomin GmbH, Industriestrasse 21,
Herzogenburg, Austria 3130. The
petition proposes to amend the food
additive regulations in part 573, Food
Additives Permitted in Feed and
Drinking Water of Animals (21 CFR part
573) to provide for the safe use of
Eubacterium bacterial species in feed
for detoxifying trichothecene
mycotoxins in the digestive tracts of
swine and poultry.
The potential environmental impact
of this action is being reviewed. To
encourage public participation
consistent with regulations issued under
the National Environmental Policy Act
(40 CFR 1501.4(b)), the agency is
placing the environmental assessment
submitted with the petition that is the
subject of this notice on public display
at the Division of Dockets Management
(see ADDRESSES) for public review and
comment.
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.
FDA will also place on public display
any amendments to, or comments on,
the petitioner’s environmental
assessment without further
announcement in the Federal Register.
If, based on its review, the agency finds
that an environmental impact statement
is not required and this petition results
in a regulation, the notice of availability
of the agency’s finding of no significant
impact and the evidence supporting that
finding will be published with the
regulation in the Federal Register in
accordance with 21 CFR 25.51(b).
sroberts on PROD1PC70 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: October 18, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–21298 Filed 10–29–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
20:46 Oct 29, 2007
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0395]
Draft Guidance for Industry on Acute
Bacterial Sinusitis: 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 ‘‘Acute Bacterial
Sinusitis: Developing Drugs for
Treatment.’’ The purpose of this
guidance is to assist clinical trial
sponsors and investigators in the
development of antimicrobial drug
products for the treatment of acute
bacterial sinusitis (ABS). The agency’s
thinking in this area has evolved in
recent years, and this draft guidance,
when finalized, will inform sponsors of
our current thinking in this area. In
addition, it will fulfill a statutory
requirement to publish such a guidance
enacted in the Food and Drug
Administration Amendments Act of
2007 (FDAAA).
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 28, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed 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.fda.gov/dockets/ecomments or
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Steve Gitterman, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6134,
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Silver Spring, MD 20993–0002, 301–
796–1600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Acute Bacterial Sinusitis: Developing
Drugs for Treatment.’’ The purpose of
this guidance is to assist clinical trial
sponsors and investigators in the
development of antimicrobial drug
products for the treatment of ABS. This
guidance revises the draft guidance
regarding ABS published in 1998.
Section 911 of the FDAAA (Public Law
110–85) adds section 511 to the Federal
Food, Drug, and Cosmetic Act that
directs the Secretary for Health and
Human Services to ‘‘issue guidance for
the conduct of clinical trials with
respect to antibiotic drugs, including
antimicrobials to treat acute bacterial
sinusitis.’’ This guidance will fulfill this
statutory requirement.
The design of clinical trials for ABS
was the subject of an Anti-Infective
Drug Products Advisory Committee
meeting on October 28, 2003. In
addition, other advisory committee
meetings have focused on the
development of specific drug products
for this indication. As a result of these
public discussions, as well as review of
pending applications at FDA, the
agency’s thinking in this area has
evolved in recent years, and this
guidance informs sponsors of the
changes in our recommendations.
Specifically, this guidance recommends
that ABS clinical trials be designed as
superiority rather than noninferiority
trials, and discusses some possible
study designs that might be employed in
an ABS trial designed to show
superiority. This guidance also
recommends that microbiological
information be obtained in at least one
of the controlled studies. This guidance
discusses patient-reported outcome
instruments for assessing clinical
response, and the use of time to
resolution as a possible approach to
assessing the primary endpoint. As
required by FDAAA, this guidance also
addresses the use of animal models and
surrogate markers in the development of
drugs for the treatment of ABS.
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 developing drugs for the treatment of
acute bacterial sinusitis. 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\30OCN1.SGM
30OCN1
Federal Register / Vol. 72, No. 209 / Tuesday, October 30, 2007 / Notices
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 part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; and the collections
of information referred to in the
guidance entitled ‘‘Establishment and
Operation of Clinical Trial Data
Monitoring Committees’’ have been
approved under OMB control number
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.fda.gov/
ohrms/dockets/default.htm.
Dated: October 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–21332 Filed 10–29–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Privacy Act of 1974: New System of
Records
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notification of new system of
records.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act, the
VerDate Aug<31>2005
20:46 Oct 29, 2007
Jkt 214001
Health Resources and Services
Administration (HRSA) is publishing a
notice of a proposal to add a new system
of records. The Campus Based Branch
(CBB) of the Division of Health Careers
Diversity and Development in the
Bureau of Health Professions is
currently utilizing a document
management system (DMS) that
dynamically manages its flow of
documents produced and received. the
DMS is an intra-office system in which
documents contained within the system
are only shared among CBB staff. The
DMS contains names and other
personally identifiable information of
borrowers.
DATES: HRSA invites interested parties
to submit comments on the proposed
New System of Records on or before
December 10, 2007. HRSA has sent a
report of a New System of Records to
Congress and to the Office of
Management and Budget (OMB) on
October 18, 2007. The New System of
Records will be effective 40 days from
the date submitted to OMB unless
HRSA comments which would result in
a contrary determination.
ADDRESSES: Please address comments to
Donn Taylor, Health Resources and
Services Administration, Privacy Act
Coordinator, 5600 Fishers Lane, Room
14A–20, Rockville, Maryland 20857;
Telephone (301) 443–0204. Comments
received will be available for inspection
at this same address from 9 a.m. to 3
p.m., Monday through Friday. this is not
a toll-free number.
FOR FURTHER INFORMATION CONTACT:
Henry Lopez, Director, division of
Health Careers diversity and
Development, Bureau of Health
Professions, 5600 Fisher Lane, Room 842, Rockville, Maryland 20857;
Telephone 301–443–1173. This is not a
toll-free number.
SUPPLEMENTARY INFORMATION: The
Health Resources and Services
Administration proposes to establish a
New System of Records: ‘‘Campus Based
Branch Programs Document
Management System, HHS/HRSA/
BHPr.’’ The CBB programs which use
the DMS are authorized by the following
sections of the Public Health Service
Act: Section 721 of the Public Health
Service Act (42 U.S.C. 292q) the Health
Professions Student Loan Program;
Section 724 of the Public Health Service
Act (42 U.S.C. 292s) the Primary Care
Loan Program; Section 724 of the Public
Health Service Act (42 U.S.C. 292t) the
Loans for Disadvantaged Students
Program; Section 835 of the Public
Health Service Act (42 U.S. C. 297a) the
Nursing Student Loan Program; and
Section 737 of the Public Health Service
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
61359
Act (42 U.S.C. 293a) the Scholarships
for Disadvantaged Students Program. In
accordance with their applicable
regulations, the funds appropriated or
distributed from these CBB programs are
monitored by the CBB. The DMS is an
automated system that enables CBB to
fulfill its duty in monitoring these
programs. The DMS contains annual
operating and performance data from
educational institutions participating in
CBB programs, as well as personally
identifiable information of borrowers.
Dated: October 12, 2007.
Elizabeth M. Duke,
Administrator.
Report of a New System of Records
09–15–0069
SYSTEM NAME:
Campus Based Branch (CBB) Program
Document Management System (DMS),
HHS/HRSA/BHPr.
SECURITY CLASSIFICATION:
None
SYSTEM LOCATION:
The Division of Health Careers
Diversity and Development (DHCDD) of
the Bureau of Health Professions (BHPr),
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
Records are located at 5600 Fishers
Lane, Room 8–42, Rockville, MD 20857.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
Student and faculty borrowers who
participate/participated in CBB loan and
scholarship programs.
CATEGORIES OF RECORDS IN THE SYSTEM:
The systems include materials such
as:
1. Names, addresses, phone numbers,
medical records, financial information,
and social security numbers of
borrowers.
2. Annual Operating Reports that
contain financial information from
institutions, including aggregate
amounts of loans disbursed, collected
and retired.
3. Performance reports on the
aggregate number of borrowers, their
classification in race/ethnicity
categories, and whether they are
practicing in primary care.
4. Contact information of financial aid
officers that include name, title, school
address and direct phone number.
5. Correspondence from the financial
aid officers regarding issues with
specific borrowers. The majority of
these correspondence only indicate the
borrower’s name and/or amount
borrowed.
E:\FR\FM\30OCN1.SGM
30OCN1
]]>Agencies
[Federal Register Volume 72, Number 209 (Tuesday, October 30, 2007)]
[Notices]
[Pages 61358-61359]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0395]
Draft Guidance for Industry on Acute Bacterial Sinusitis:
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 ``Acute
Bacterial Sinusitis: Developing Drugs for Treatment.'' The purpose of
this guidance is to assist clinical trial sponsors and investigators in
the development of antimicrobial drug products for the treatment of
acute bacterial sinusitis (ABS). The agency's thinking in this area has
evolved in recent years, and this draft guidance, when finalized, will
inform sponsors of our current thinking in this area. In addition, it
will fulfill a statutory requirement to publish such a guidance enacted
in the Food and Drug Administration Amendments Act of 2007 (FDAAA).
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 28, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-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 (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to https://www.fda.gov/dockets/
ecomments or https://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Steve Gitterman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6134, Silver Spring, MD 20993-0002, 301-
796-1600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.''
The purpose of this guidance is to assist clinical trial sponsors and
investigators in the development of antimicrobial drug products for the
treatment of ABS. This guidance revises the draft guidance regarding
ABS published in 1998. Section 911 of the FDAAA (Public Law 110-85)
adds section 511 to the Federal Food, Drug, and Cosmetic Act that
directs the Secretary for Health and Human Services to ``issue guidance
for the conduct of clinical trials with respect to antibiotic drugs,
including antimicrobials to treat acute bacterial sinusitis.'' This
guidance will fulfill this statutory requirement.
The design of clinical trials for ABS was the subject of an Anti-
Infective Drug Products Advisory Committee meeting on October 28, 2003.
In addition, other advisory committee meetings have focused on the
development of specific drug products for this indication. As a result
of these public discussions, as well as review of pending applications
at FDA, the agency's thinking in this area has evolved in recent years,
and this guidance informs sponsors of the changes in our
recommendations. Specifically, this guidance recommends that ABS
clinical trials be designed as superiority rather than noninferiority
trials, and discusses some possible study designs that might be
employed in an ABS trial designed to show superiority. This guidance
also recommends that microbiological information be obtained in at
least one of the controlled studies. This guidance discusses patient-
reported outcome instruments for assessing clinical response, and the
use of time to resolution as a possible approach to assessing the
primary endpoint. As required by FDAAA, this guidance also addresses
the use of animal models and surrogate markers in the development of
drugs for the treatment of ABS.
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 developing
drugs for the treatment of acute bacterial sinusitis. 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 61359]]
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 part 312 have been
approved under OMB control number 0910-0014; the collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001; and the collections of information referred to in the
guidance entitled ``Establishment and Operation of Clinical Trial Data
Monitoring Committees'' have been approved under OMB control number
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.fda.gov/ohrms/dockets/default.htm.
Dated: October 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21332 Filed 10-29-07; 8:45 am]
BILLING CODE 4160-01-S
