Sex Differences in the Cardiovascular Device Trials; Public Workshop, 72063-72064 [E8-28169]
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Federal Register / Vol. 73, No. 229 / Wednesday, November 26, 2008 / Notices
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mstockstill on PROD1PC66 with NOTICES
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VerDate Aug<31>2005
17:30 Nov 25, 2008
Jkt 217001
management system. Electronic
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Dated: November 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28189 Filed 11–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Sex Differences in the Cardiovascular
Device Trials; 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 entitled ‘‘Sex
Differences in the Cardiovascular Device
Trials.’’ FDA is co-sponsoring the
conference with the Advanced Medical
Technology Association (AdvaMed).
The purpose of the workshop is to
facilitate discussion between FDA and
other interested parties on the study and
analysis of sex and gender differences in
cardiovascular medical device trials, in
anticipation of issuance of draft
guidance on this subject.
DATES: The workshop will be held on
December 9, 2008, from 9 a.m. to 5 p.m.
Participants are encouraged to arrive
early to ensure time for parking and
security screening before the meeting.
Security screening will begin at 8 a.m.
and reception will begin at 8:30 a.m.
Please register by December 2, 2008,
using the instructions in this document.
Non-U.S. citizens are subject to
additional security screening and
should register as soon as possible.
ADDRESSES: The workshop will be held
at the FDA White Oak Campus, 10903
New Hampshire Ave., Silver Spring, MD
20993.
FOR FURTHER INFORMATION CONTACT:
Kathryn O’Callaghan, Center for Devices
and Radiological Health (HFZ–450),
Food and Drug Administration, 9200
Corporate Blvd., rm. 230D, 240–276–
4182, Rockville, MD 20850,
kathryn.ocallaghan@fda.hhs.gov; or
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
72063
Ashley Boam, Center for Devices and
Radiological Health (HFZ–450), Food
and Drug Administration, 9200
Corporate Blvd., rm. 230J, 240–276–
4188, Rockville, MD 20850,
ashley.boam@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public
Workshop?
The purpose of the public workshop
is to facilitate discussion between FDA
and other interested parties on the study
and analysis of sex and gender
differences in cardiovascular medical
device trials, in anticipation of issuance
of draft guidance on this subject.
II. What Are the Topics We Intend to
Address at the Public Workshop?
We hope to discuss a large number of
issues at the public workshop,
including, but not limited to:
• Current FDA perspective on sex/
gender differences in pharmaceutical
and medical device evaluation.
• Medical device development in the
U.S. regulatory environment.
• Sex/gender-specific considerations
in product design and clinical study
design.
• The current state of cardiovascular
treatment for women.
• Referral biases for women at risk for
cardiovascular disease.
• The Clinical Research Organization
and Institutional Review Board
perspectives on inclusion, exclusion,
recruitment, and retention issues related
to women in clinical trials.
• The investigator/clinician
perspective on the impact of sex/genderspecific issues on study design and
conduct and available treatment options
and limitations of use in women.
• The female patient perspective on
enrollment and participation in clinical
trials.
• The biostatistician perspective on
statistical approaches and subgroup
analysis in significant subpopulations.
• Case studies on gender-specific
trials.
III. Is There a Fee and How Do I
Register for the Public Workshop?
There is a modest fee to attend the
conference to defray the costs of meals
provided and other expenses. The fee
for the meeting for registrants from
industry is $125.00, and the fee for
government registrants is $75.00. Fees
will be waived for invited speakers and
panelists. The registration process will
be handled by AdvaMed, which has
extensive experience in planning,
executing, and organizing educational
meetings. Register online at https://
www.AdvaMed.org. Although the
E:\FR\FM\26NON1.SGM
26NON1
72064
Federal Register / Vol. 73, No. 229 / Wednesday, November 26, 2008 / Notices
facility is spacious, registration will be
on a first-come, first-served basis. NonU.S. citizens are subject to additional
security screening, and should register
as soon as possible.
If you need special accommodations
because of a disability, please contact
Kathryn O’Callaghan at least 7 days
before the public workshop.
IV. Where Can I Find Out More About
This Public Workshop?
Background information on the public
workshop, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at https://www.AdvaMed.org and
https://www.fda.gov/cdrh/dsma/
workshop.html.
Dated: November 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28169 Filed 11–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Patient Navigator
Outreach and Chronic Disease
Prevention Demonstration Program
Patient Data Collection Form—NEW
The purpose of the Patient Navigator
Outreach and Chronic Disease
Prevention (PN) Demonstration Program
is to promote model ‘‘patient navigator’’
programs to improve health care
outcomes for individuals with cancer
and/or other chronic diseases, with a
specific emphasis on health disparity
populations. This program aims to
coordinate comprehensive health
services for patients in need of chronic
disease care and management through
enhanced chronic disease management
provided by patient navigators.
In order to describe successful PN
program models and make
recommendations on the ability of such
programs to improve patient outcomes,
data is needed at the individual patient,
Responses
per
respondent
Number of
respondents
Form
patient navigator, and PN program
levels. This information includes:
• Sociodemographics of patients (e.g.,
insurance status, income, education
level, gender, age, race and ethnicity,
primary language, number of family
dependents) served;
• Patient access barriers to standard
chronic disease care (e.g., access to
pharmaceuticals, distance of patient’s
home from health care facilities utilized,
primary mode of transportation to
health care facilities utilized, cultural
and linguistic barriers as well as literacy
levels);
• Health care service utilization (e.g.,
screening rates, compliance rate for
appointments and follow-up exams,
time interval between diagnosis or
referral and resolution date);
• Patient health status (e.g., type and
stage of diagnosis, chronic disease
status, final outcome or result); and
• Patient navigation data (e.g., type of
navigator, patient navigation training
plans and outcomes, point at which
patient navigator was brought into the
process, number of patients referred,
how patient barriers were resolved,
patient satisfaction, follow-up
outcomes—such as number of
uninsured who get health coverage).
This information will be collected
from patients or their designated
caregiver, patient navigators, and PN
program administrators. Maintaining
confidentiality of patient medical
information is a concern and thus all
personal information will be deidentified to protect the confidentiality
of all patients. Data collection and
disclosure processes will abide by
Health Insurance Portability and
Accountability Act (HIPPA) Privacy
Rule provisions and procedures. The
estimated annual burden is as follows:
Total
responses
Hours per
response
Total burden
hours
6,000
6,000
1
1
6,000
6,000
0.5
0.25
3,000
1,500
SubTotal—Patient Burden ............................................
6,000
2
1,2000
0.75
4,500
Patient Navigator Survey .....................................................
Patient Navigator Encounter/Tracking Log 2 ........................
30
30
1
750
30
22,500
0.25
0.25
7.5
5,625
SubTotal—Patient Navigator Burden ...........................
30
751
22,530
0.5
5,632.5
Grantee PN Administrative Records 3 .................................
Medical Record and Clinic Data 4 ........................................
mstockstill on PROD1PC66 with NOTICES
Navigated Patient 1 Data Intake Form .................................
Navigated Patient Satisfaction Survey ................................
6
6
1
2,000
6
12,000
0.5
2
3
24,000
SubTotal—Grantee Burden ..........................................
12
2,001
12,012
2.5
24,006
Total Average Annual Burden ...............................
6,052
2,754
54,052
3.75
36,016
1 Estimated
number of navigated patients per year based on applications was rounded to 6000. See table below for projected numbers navigated by Grantee.
2 Assumes 5 log entries of PN activities per patient.
VerDate Aug<31>2005
17:30 Nov 25, 2008
Jkt 217001
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
E:\FR\FM\26NON1.SGM
26NON1
]]>Agencies
[Federal Register Volume 73, Number 229 (Wednesday, November 26, 2008)]
[Notices]
[Pages 72063-72064]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28169]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Sex Differences in the Cardiovascular Device Trials; 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 entitled ``Sex Differences in the Cardiovascular Device
Trials.'' FDA is co-sponsoring the conference with the Advanced Medical
Technology Association (AdvaMed). The purpose of the workshop is to
facilitate discussion between FDA and other interested parties on the
study and analysis of sex and gender differences in cardiovascular
medical device trials, in anticipation of issuance of draft guidance on
this subject.
DATES: The workshop will be held on December 9, 2008, from 9 a.m. to 5
p.m. Participants are encouraged to arrive early to ensure time for
parking and security screening before the meeting. Security screening
will begin at 8 a.m. and reception will begin at 8:30 a.m. Please
register by December 2, 2008, using the instructions in this document.
Non-U.S. citizens are subject to additional security screening and
should register as soon as possible.
ADDRESSES: The workshop will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Silver Spring, MD 20993.
FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., rm. 230D, 240-276-4182,
Rockville, MD 20850, kathryn.ocallaghan@fda.hhs.gov; or
Ashley Boam, Center for Devices and Radiological Health (HFZ-450),
Food and Drug Administration, 9200 Corporate Blvd., rm. 230J, 240-276-
4188, Rockville, MD 20850, ashley.boam@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public Workshop?
The purpose of the public workshop is to facilitate discussion
between FDA and other interested parties on the study and analysis of
sex and gender differences in cardiovascular medical device trials, in
anticipation of issuance of draft guidance on this subject.
II. What Are the Topics We Intend to Address at the Public Workshop?
We hope to discuss a large number of issues at the public workshop,
including, but not limited to:
Current FDA perspective on sex/gender differences in
pharmaceutical and medical device evaluation.
Medical device development in the U.S. regulatory
environment.
Sex/gender-specific considerations in product design and
clinical study design.
The current state of cardiovascular treatment for women.
Referral biases for women at risk for cardiovascular
disease.
The Clinical Research Organization and Institutional
Review Board perspectives on inclusion, exclusion, recruitment, and
retention issues related to women in clinical trials.
The investigator/clinician perspective on the impact of
sex/gender-specific issues on study design and conduct and available
treatment options and limitations of use in women.
The female patient perspective on enrollment and
participation in clinical trials.
The biostatistician perspective on statistical approaches
and subgroup analysis in significant subpopulations.
Case studies on gender-specific trials.
III. Is There a Fee and How Do I Register for the Public Workshop?
There is a modest fee to attend the conference to defray the costs
of meals provided and other expenses. The fee for the meeting for
registrants from industry is $125.00, and the fee for government
registrants is $75.00. Fees will be waived for invited speakers and
panelists. The registration process will be handled by AdvaMed, which
has extensive experience in planning, executing, and organizing
educational meetings. Register online at https://www.AdvaMed.org.
Although the
[[Page 72064]]
facility is spacious, registration will be on a first-come, first-
served basis. Non-U.S. citizens are subject to additional security
screening, and should register as soon as possible.
If you need special accommodations because of a disability, please
contact Kathryn O'Callaghan at least 7 days before the public workshop.
IV. Where Can I Find Out More About This Public Workshop?
Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
https://www.AdvaMed.org and https://www.fda.gov/cdrh/dsma/workshop.html.
Dated: November 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28169 Filed 11-25-08; 8:45 am]
BILLING CODE 4160-01-S
