Clinical Development of Drugs for the Prevention of Infections Caused by Staphylococcus aureus in the Health Care Setting; Public Workshop, 47654-47655 [2014-19257]
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Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0622]
Draft Guidance for Industry on Best
Practices in Developing Proprietary
Names for Drugs; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the draft guidance
entitled ‘‘Best Practices in Developing
Proprietary Names for Drugs,’’ which
published in the Federal Register of
May 29, 2014 (79 FR 30852). FDA is
reopening the comment period in
response to several requests for
additional time and to allow interested
persons more time to submit comments.
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considers your comments on this draft
guidance before it begins work on the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on the draft guidance by September 15,
2014.
ADDRESSES: Submit electronic
comments 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:
Kellie Taylor, Center for Drug
Evaluation and Research, Food and
Drug Administration, Office of
Surveillance and Epidemiology, 10903
New Hampshire Ave., Bldg. 22, Rm.
4418, Silver Spring, MD 20993–0002,
301–796–0157.
SUPPLEMENTARY INFORMATION:
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
In the Federal Register of May 29,
2014 (79 FR 30852), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Best Practices in
Developing Proprietary Names for
Drugs.’’ In that document, FDA
requested comments on the draft
guidance, which describes best practices
for developing and selecting proposed
proprietary names to minimize
medication errors. Interested persons
were originally given until July 28,
2014, to submit comments on the draft
guidance to ensure that the Agency
16:42 Aug 13, 2014
[FR Doc. 2014–19261 Filed 8–13–14; 8:45 am]
Staphylococcus aureus infections
including the design of clinical trials.
The input from this public workshop
will help in developing topics for
further discussion.
Date and Time: The public workshop
will be held on September 5, 2014, from
8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the DoubleTree by Hilton
Hotel Washington DC, 8727 Colesville
Rd., Silver Spring, MD 20910. The
hotel’s phone number is 301–589–5200.
Contact Persons: Carole Miller or Lori
Benner, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6217, Silver Spring,
MD 20993–0002, 301–796–1300.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early. Seating
is limited and will be available on a
first-come, first-served basis. To register
electronically, email registration
information (including name, title, firm
name, address, telephone, and fax
number) to FDASTAPHWORKSHOP@
fda.hhs.gov. Onsite registration the day
of the workshop will be available, but
advanced registration is preferred.
Persons without access to the Internet
can call 301–796–1300 to register.
If you need a sign language interpreter
or other special accommodations, please
notify Carole Miller or Lori Benner (see
Contact Persons) at least 7 days in
advance.
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION:
II. How to Submit 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.
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Clinical Development of Drugs for the
Prevention of Infections Caused by
Staphylococcus aureus in the Health
Care Setting; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
I. Background
VerDate Mar<15>2010
considers their comments before it
begins work on the final version of the
guidance.
The Agency has received several
requests to reopen the comment period
for an additional 60 days. The requests
conveyed concern that the original 60day comment period did not allow
sufficient time to develop a meaningful
or thoughtful response.
FDA has considered the requests and
will reopen the comment period for an
additional 30 days. The Agency believes
that an additional 30 days allows
adequate time for interested persons to
submit comments without significantly
delaying the Agency’s consideration of
these important issues.
Jkt 232001
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop regarding the clinical
development of drugs for the prevention
of serious infections caused by
Staphylococcus aureus in the health
care setting. This public workshop is
intended to provide information for and
gain perspective from health care
providers, patients and patient advocacy
organizations, academia, and industry
on various aspects of clinical
development of drugs to prevent
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
FDA is announcing a public
workshop regarding scientific
considerations in the clinical
development of drugs for the prevention
of serious infections caused by
Staphylococcus aureus in the health
care setting. Clinical care guidelines
recommend a group of interventions to
reduce health care associated infections
in certain patients (for example, surgical
patients, patients with a central-line
catheter such as dialysis patients, and
patients admitted to the intensive care
unit). Some experts recommend specific
interventions (such as nasal
decolonization) to prevent infections
caused by Staphylococcus aureus.
Discussions will focus on the data that
may demonstrate a clinical benefit in
different populations of patients. In
addition, discussions will include: (1)
Possible approaches to demonstrating
the clinical benefit of one intervention
component in the setting of a group of
interventions, (2) feasible approaches to
identifying and recruiting patients at
increased risk for serious infections
caused by Staphylococcus aureus in
clinical trials, and (3) feasible clinical
E:\FR\FM\14AUN1.SGM
14AUN1
Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
trial designs that may provide evidence
of efficacy to support drug approval.
The Agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be
available on the Internet at https://
www.fda.gov/Drugs/NewsEvents/
ucm132703.htm approximately 45 days
after the workshop.
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19257 Filed 8–13–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0334]
Postmarketing Safety Reports for
Human Drug and Biological Products;
Electronic Submission Requirements;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
final rule entitled ‘‘Postmarketing Safety
Reports for Human Drug and Biological
Products; Electronic Submission
Requirements’’ that appeared in the
Federal Register of June 10, 2014 (79 FR
33072). The document amended FDA’s
postmarketing safety reporting
regulations for human drug and
biological products to require that
persons subject to mandatory reporting
requirements submit safety reports in an
electronic format that FDA can process,
review, and archive. The document was
published with incorrect information
regarding the availability of the
International Conference on
Harmonization’s (ICH) data elements for
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:42 Aug 13, 2014
Jkt 232001
postmarketing safety reports. The
document also published with an
incorrect statement regarding the impact
of the final rule on small entities. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Jean
Chung, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4466, Silver Spring,
MD 20993–0002, 301–796–1874; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 10, 2014, in FR
Doc. 2014–13480, the following
corrections are made:
1. On page 33074, in the first column,
under ‘‘Introduction’’, footnote 6 is
corrected to read: ‘‘ICH data elements
for postmarketing safety reports are
provided in the guidance for industry
entitled ‘E2B Electronic Transmission of
Individual Case Safety Reports
Implementation Guide—Data Elements
and Message Specification,’ available at
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.’’
2. On page 33084, in the second
column, under ‘‘Analysis of Impacts’’,
the first full sentence is corrected to
read: ‘‘Because the average small entity
submits few safety reports and the
Agency’s Web-based system for
submitting reports electronically will
require little additional cost per report,
the Agency certifies that this final rule
will not have a significant economic
impact on a substantial number of small
entities.’’
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19255 Filed 8–13–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
PO 00000
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47655
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than September 15,
2014.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Federal Tort Claims Act (FTCA) Free
Clinic Application OMB No. 0915–
0293—Revision.
Abstract: Under 42 U.S.C. 233(o) and
Program Assistance Letter (PAL) 2014–
04, ‘‘Calendar Year 2015 Federal Tort
Claims Act (FTCA) Deeming
Application for Free Clinics,’’ free
clinics are required to submit annual
applications for deeming of qualified
health care professionals, board
members, officers, and contractors for
purposes of FTCA medical malpractice
coverage for negligent acts and
omissions that arise from the
performance of medical, surgical,
dental, or related functions within the
scope of the covered individual’s
deemed employment. HRSA proposes
modifying the application forms to
reflect changes to eligible personnel
made by section 10608 of the Affordable
Care Act, which extended FTCA
medical malpractice liability protection
to free clinic board members, officers,
employees, and contractors.
Additionally, HRSA proposes upgrading
the application to provide for electronic
submissions. Specifically, the
modifications include: (1) Inclusion of
board members, officers, employees,
and contractors into one comprehensive
application that also includes volunteer
health care professionals and (2) a fully
electronic application that can be
submitted via HRSA’s web-based
application system, the Electronic
Handbooks (EHBs). It is anticipated that
SUMMARY:
E:\FR\FM\14AUN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47654-47655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19257]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Clinical Development of Drugs for the Prevention of Infections
Caused by Staphylococcus aureus in the Health Care Setting; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding the clinical development of drugs for the prevention
of serious infections caused by Staphylococcus aureus in the health
care setting. This public workshop is intended to provide information
for and gain perspective from health care providers, patients and
patient advocacy organizations, academia, and industry on various
aspects of clinical development of drugs to prevent Staphylococcus
aureus infections including the design of clinical trials. The input
from this public workshop will help in developing topics for further
discussion.
Date and Time: The public workshop will be held on September 5,
2014, from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the DoubleTree by
Hilton Hotel Washington DC, 8727 Colesville Rd., Silver Spring, MD
20910. The hotel's phone number is 301-589-5200.
Contact Persons: Carole Miller or Lori Benner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6217, Silver Spring, MD 20993-0002, 301-
796-1300.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early. Seating is limited
and will be available on a first-come, first-served basis. To register
electronically, email registration information (including name, title,
firm name, address, telephone, and fax number) to
FDASTAPHWORKSHOP@fda.hhs.gov. Onsite registration the day of the
workshop will be available, but advanced registration is preferred.
Persons without access to the Internet can call 301-796-1300 to
register.
If you need a sign language interpreter or other special
accommodations, please notify Carole Miller or Lori Benner (see Contact
Persons) at least 7 days in advance.
SUPPLEMENTARY INFORMATION:
FDA is announcing a public workshop regarding scientific
considerations in the clinical development of drugs for the prevention
of serious infections caused by Staphylococcus aureus in the health
care setting. Clinical care guidelines recommend a group of
interventions to reduce health care associated infections in certain
patients (for example, surgical patients, patients with a central-line
catheter such as dialysis patients, and patients admitted to the
intensive care unit). Some experts recommend specific interventions
(such as nasal decolonization) to prevent infections caused by
Staphylococcus aureus. Discussions will focus on the data that may
demonstrate a clinical benefit in different populations of patients. In
addition, discussions will include: (1) Possible approaches to
demonstrating the clinical benefit of one intervention component in the
setting of a group of interventions, (2) feasible approaches to
identifying and recruiting patients at increased risk for serious
infections caused by Staphylococcus aureus in clinical trials, and (3)
feasible clinical
[[Page 47655]]
trial designs that may provide evidence of efficacy to support drug
approval.
The Agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm approximately 45 days after
the workshop.
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19257 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P
