Submission for OMB Review; 30-day Comment Request: The Framingham Heart Study (FHS), 58318-58320 [2013-23060]
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Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
protocols for devices used to treat/
diagnose rare pediatric diseases?
3. What barriers related to statistical
analyses must be addressed in order to
promote device development for rare
pediatric diseases?
4. How can new registries be
developed or current registries be
leveraged to provide robust data on the
safety and effectiveness of pediatric
medical devices to support premarket
approval and clearance, and/or enhance
postmarket surveillance activities
related to pediatric medical devices?
E. Pediatric Needs Assessment
1. Describe the parameters that should
be used in determining priority areas of
development of devices, including both
therapeutic and diagnostic devices, in
pediatric rare diseases.
2. What is the best approach to
conduct needs assessment of medical
devices required for use with pediatric
rare diseases?
F. Device Related Issues for Diagnostic
Devices
1. What are medical device related
issues that need to be addressed for
development of diagnostic medical
devices?
emcdonald on DSK67QTVN1PROD with NOTICES
G. Advancing Development
1. What incentives could help
advance the development of diagnostic
and therapeutic medical devices to treat
pediatric rare diseases?
2. How can possible or probable use
in pediatric practice be considered early
in the development stages of all devices
designed to treat a rare disease or
condition?
3. What are potential private
resources (e.g., registries, industry, or
patient advocacy groups) that could be
tapped to advance the development of
medical devices for rare diseases in the
pediatric population?
4. What are potential improvements
or changes that can be made to FDA
guidance, regulations, or current science
in order to help develop and improve
medical devices to address the needs of
the pediatric population affected by rare
diseases?
Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22960 Filed 9–20–13; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Clinical Trial Design for Intravenous
Fat Emulsion Products; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration’s
(FDA) Center for Drug Evaluation and
Research, in cosponsorship with the
American Society for Parenteral and
Enteral Nutrition, is announcing a 1-day
public workshop entitled ‘‘Clinical Trial
Design for Intravenous Fat Emulsion
Products.’’ This workshop will provide
a forum to discuss trial design of
clinical trials intended to support
registration of intravenous fat emulsion
products.
Date and Time: The public workshop
will be held on October 29, 2013, from
8 a.m. to 5 p.m. (EST).
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Contact Person: Wes Ishihara, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–0069, FAX: 301–
796–9904, email: richard.ishihara@
fda.hhs.gov.
Registration: There is no fee to attend
the public workshop, but attendees
must register in advance. Space is
limited, and registration will be on a
first-come, first-served basis. Persons
interested in attending this workshop
must register online at https://
netforum.avectra.com/eweb/
DynamicPage.aspx?Site=ASPEN&
WebCode=EventDetail&evt_key=
eb9c4068-8b66-4ac0-ae4f-ac266c08e33e
before October 22, 2013. For those
without Internet access, please contact
Wes Ishihara (see Contact Person) to
register. On-site registration will not be
available.
If you need special accommodations
because of disability, please contact Wes
Ishihara (see Contact Person) at least 7
days in advance.
SUPPLEMENTARY INFORMATION: This
workshop will provide a forum to
discuss the key issues in clinical trial
design for intravenous fat emulsions.
Stakeholders, including industry
sponsors, academia, patients receiving
parenteral nutrition, and FDA, will
discuss challenging issues related to
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selection of endpoints and assessment
methodologies in registration trials.
Trial design strategies and possible
candidates for endpoints will be
explored.
Transcripts: Transcripts of the
workshop will be available for review at
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and on the
Internet at https://www.regulations.gov
approximately 30 days after the
workshop. A transcript will also be
available in either hard copy or on CD–
ROM, after submission of a Freedom of
Information request. Send written
requests to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Rockville, MD 20857. Send faxed
requests to 301–827–9267.
Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23020 Filed 9–20–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request: The Framingham
Heart Study (FHS)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on May 7, 2013,
pages 26639–41 and allowed 60-days for
public comment. No public comments
were received. The National Heart,
Lung, and Blood Institute (NHLBI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
SUMMARY:
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Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
data collection plans and instruments,
contact Dr. Gina Wei, Division of
Cardiovascular Sciences, NHLBI, NIH,
Two Rockledge Center, 6701 Rockledge
Drive, MSC 7936, Bethesda, MD, 20892–
7936, or call non-toll-free number (301)
435–0416, or email your request,
including your address to: weig@
nhlbi.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: The Framingham
Heart Study, 0925–0216, Revision
National Heart, Lung, and Blood
Institute (NHLBI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The Framingham Heart
Study will continue to conduct
morbidity and mortality follow-up, as
well as examinations, for the purpose of
studying the determinants of
cardiovascular disease. Morbidity and
mortality follow-up will continue to
occur in all of the cohorts (Original,
Offspring, Third Generation, Omni
Group 1, and Omni Group 2).
Examinations will continue to be
conducted on the Original, Offspring,
and Omni Group 1 Cohorts. The
numbers of Offspring and Omni Group
1 participants to be examined for this
OMB submission are much smaller than
those during the last OMB approval
period. This is because a great majority
of these two cohorts have already
completed their examinations. The
small number of participants remaining
to be examined is reflected in the
decrease in the estimated annualized
burden hours for these two cohorts as
well as for the entire study, compared
to the last OMB approval period.
OMB approval is requested for 3
years. There is no cost to the
respondents other than their time. The
total estimated annualized burden hours
are 4264.
ESTIMATED ANNUALIZED BURDEN HOURS, ORIGINAL COHORT
Number of
responses per
respondent
Number of
respondents
Type of respondent
I. PARTICIPANT COMPONENTS
A. PRE-EXAM:.
a. Telephone contact to set up appointment ............................
b. Exam Appointment, Scheduling, Reminder, and Instructions
B. EXAM—Cycle 32:.
a. Clinic exam ............................................................................
b. Home or nursing home visit ..................................................
C. ANNUAL FOLLOW-UP:.
a. Records Request ..................................................................
b. Health Status Update ............................................................
Average time
per response
(in hours)
Total annual
burden hour
60
55
1
1
10/60
35/60
10
32
25
25
1
1
45/60
65/60
19
27
60
45
1
1
15/60
15/60
15
11
SUB-TOTAL: PARTICIPANT COMPONENTS ..................
*60
..........................
..........................
114
II. NON-PARTICIPANT COMPONENTS
A. Informant Contact (Pre-exam and Annual Follow-up) .................
B. Records Request (Annual follow-up) ...........................................
25
50
1
1
10/60
15/60
4
13
SUB-TOTAL: NON-PARTICIPANT COMPONENTS .........
75
..........................
..........................
17
* Number of participants as reflected in Rows I.A.a and I.C.a. above
ESTIMATED ANNUALIZED BURDEN HOURS, OFFSPRING COHORT AND OMNI GROUP 1 COHORT
Number of
respondents
Type of respondent
emcdonald on DSK67QTVN1PROD with NOTICES
I. PARTICIPANT COMPONENTS
A. PRE-EXAM:
a. Telephone contact to set up apt or Health status update ............
b. Appt. or update Confirmation ........................................................
c. Food Frequency Form ...................................................................
B. EXAM:
a. Clinic Exam ...................................................................................
b. Home or nursing home visit ..........................................................
c. Consent Forms ..............................................................................
C. ANNUAL FOLLOW-UP:
a. Records Request ...........................................................................
b. Health Status Update ....................................................................
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hour
300
250
250
1
1
1
10/60
10/60
10/60
50
42
42
100
100
200
1
1
1
175/60
60/60
20/60
292
100
67
2292
1833
1
1
15/60
15/60
573
458
SUB-TOTAL: PARTICIPANT COMPONENTS ..........................
*2292
........................
........................
1624
II. NON-PARTICIPANT COMPONENTS
A. Informant contact (Pre-exam and Annual Follow-up) ..........................
B. Records Request (Annual follow-up) ...................................................
229
2292
1
1
10/60
15/60
38
573
SUB-TOTAL: NON-PARTICIPANT COMPONENTS .................
2521
........................
........................
611
* Number of participants as reflected in Rows I.C.a. above.
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Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS, GENERATION 3 COHORT AND OMNI GROUP 2 COHORT
Number of
responses per
respondent
Number of
respondents
Type of respondent
I. PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP
A. Records Request .................................................................................
B. Health Status Update ...........................................................................
Average time
per response
(in hours)
Total annual
burden hour
3212
3212
1
1
15/60
15/60
803
803
SUB-TOTAL: PARTICIPANT COMPONENTS ..................................
II. NON-PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP
A. Informant contacts ...............................................................................
B. Records Request .................................................................................
* 3212
........................
........................
1606
160
1060
1
1
10/60
15/60
27
265
SUB-TOTAL: NON-PARTICIPANT COMPONENTS ........................
1220
........................
........................
292
* Number of participants as reflected in Rows I.A. and I.B. above.
SUMMARY OF 3 TABLES COMBINED—TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Number of responses per
respondent
Participants ......................................................................................................
Non-Participants ..............................................................................................
5564
3816
1
1
36/60
14.5/60
3344
920
Totals ........................................................................................................
9380
........................
........................
4264
Type of respondent
Average time
per response
(in hours)
Total annual
burden hour
(NOTE: reported and calculated numbers differ slightly due to rounding.)
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013–23060 Filed 9–20–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
emcdonald on DSK67QTVN1PROD with NOTICES
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 USC,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel GOMED:
Grand Opportunity in Medications
Development for Substance-Related
Disorders (U01).
Date: October 15, 2013.
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20:16 Sep 20, 2013
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Time: 9:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Washington, DC/
Bethesda, 7301 Waverly Street, Bethesda, MD
21045.
Contact Person: Jose F. Ruiz, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, Room 4228, MSC 9550,
6001 Executive Blvd., Bethesda, MD 20892–
9550, (301) 451–3086, ruizjf@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel Strategic
Alliances for Medications Development to
Treat Substance Use Disorders (R01) (PAS–
12–122).
Date: October 15, 2013.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Washington, DC/
Bethesda, 7301 Waverly Street, Bethesda, MD
21045.
Contact Person: Jose F. Ruiz, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, Room 4228, MSC 9550,
6001 Executive Blvd., Bethesda, MD 20892–
9550, (301) 451–3086, ruizjf@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Medications Development Centers of
Excellence Cooperative Program.
Date: October 15–16, 2013.
Time: 2:00 p.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Washington, DC/
Bethesda, 7301 Waverly Street, Bethesda, MD
21045.
Contact Person: Jose F. Ruiz, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
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Drug Abuse, NIH, Room 4228, MSC 9550,
6001 Executive Blvd., Bethesda, MD 20892–
9550, (301) 451–3086, ruizjf@nida.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: September 17, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–22992 Filed 9–20–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
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
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58318-58320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23060]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day Comment Request: The Framingham
Heart Study (FHS)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on May 7, 2013, pages 26639-41 and allowed 60-days for public
comment. No public comments were received. The National Heart, Lung,
and Blood Institute (NHLBI), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
[[Page 58319]]
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of data collection plans and
instruments, contact Dr. Gina Wei, Division of Cardiovascular Sciences,
NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC 7936,
Bethesda, MD, 20892-7936, or call non-toll-free number (301) 435-0416,
or email your request, including your address to: weig@nhlbi.nih.gov.
Formal requests for additional plans and instruments must be requested
in writing.
Proposed Collection: The Framingham Heart Study, 0925-0216,
Revision National Heart, Lung, and Blood Institute (NHLBI), National
Institutes of Health (NIH).
Need and Use of Information Collection: The Framingham Heart Study
will continue to conduct morbidity and mortality follow-up, as well as
examinations, for the purpose of studying the determinants of
cardiovascular disease. Morbidity and mortality follow-up will continue
to occur in all of the cohorts (Original, Offspring, Third Generation,
Omni Group 1, and Omni Group 2). Examinations will continue to be
conducted on the Original, Offspring, and Omni Group 1 Cohorts. The
numbers of Offspring and Omni Group 1 participants to be examined for
this OMB submission are much smaller than those during the last OMB
approval period. This is because a great majority of these two cohorts
have already completed their examinations. The small number of
participants remaining to be examined is reflected in the decrease in
the estimated annualized burden hours for these two cohorts as well as
for the entire study, compared to the last OMB approval period.
OMB approval is requested for 3 years. There is no cost to the
respondents other than their time. The total estimated annualized
burden hours are 4264.
Estimated Annualized Burden Hours, Original Cohort
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. PARTICIPANT COMPONENTS
A. PRE-EXAM:............................
a. Telephone contact to set up 60 1 10/60 10
appointment........................
b. Exam Appointment, Scheduling, 55 1 35/60 32
Reminder, and Instructions.........
B. EXAM--Cycle 32:......................
a. Clinic exam...................... 25 1 45/60 19
b. Home or nursing home visit....... 25 1 65/60 27
C. ANNUAL FOLLOW-UP:....................
a. Records Request.................. 60 1 15/60 15
b. Health Status Update............. 45 1 15/60 11
----------------------------------------------------------------------------------------------------------------
SUB-TOTAL: PARTICIPANT *60 ............... ............... 114
COMPONENTS.....................
----------------------------------------------------------------------------------------------------------------
II. NON-PARTICIPANT COMPONENTS
A. Informant Contact (Pre-exam and 25 1 10/60 4
Annual Follow-up)......................
B. Records Request (Annual follow-up)... 50 1 15/60 13
----------------------------------------------------------------------------------------------------------------
SUB-TOTAL: NON-PARTICIPANT 75 ............... ............... 17
COMPONENTS.....................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A.a and I.C.a. above
Estimated Annualized Burden Hours, Offspring Cohort and Omni Group 1 Cohort
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. PARTICIPANT COMPONENTS
A. PRE-EXAM:
a. Telephone contact to set up apt or 300 1 10/60 50
Health status update...................
b. Appt. or update Confirmation......... 250 1 10/60 42
c. Food Frequency Form.................. 250 1 10/60 42
B. EXAM:
a. Clinic Exam.......................... 100 1 175/60 292
b. Home or nursing home visit........... 100 1 60/60 100
c. Consent Forms........................ 200 1 20/60 67
C. ANNUAL FOLLOW-UP:
a. Records Request...................... 2292 1 15/60 573
b. Health Status Update................. 1833 1 15/60 458
---------------------------------------------------------------
SUB-TOTAL: PARTICIPANT COMPONENTS... *2292 .............. .............. 1624
----------------------------------------------------------------------------------------------------------------
II. NON-PARTICIPANT COMPONENTS
A. Informant contact (Pre-exam and Annual 229 1 10/60 38
Follow-up).................................
B. Records Request (Annual follow-up)....... 2292 1 15/60 573
---------------------------------------------------------------
SUB-TOTAL: NON-PARTICIPANT 2521 .............. .............. 611
COMPONENTS.........................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.C.a. above.
[[Page 58320]]
Estimated Annualized Burden Hours, Generation 3 Cohort and Omni Group 2 Cohort
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. PARTICIPANT COMPONENTS--ANNUAL FOLLOW-UP
A. Records Request.......................... 3212 1 15/60 803
B. Health Status Update..................... 3212 1 15/60 803
---------------------------------------------------------------
SUB-TOTAL: PARTICIPANT COMPONENTS....... * 3212 .............. .............. 1606
II. NON-PARTICIPANT COMPONENTS--ANNUAL FOLLOW-UP
A. Informant contacts....................... 160 1 10/60 27
B. Records Request.......................... 1060 1 15/60 265
---------------------------------------------------------------
SUB-TOTAL: NON-PARTICIPANT COMPONENTS... 1220 .............. .............. 292
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A. and I.B. above.
Summary of 3 Tables Combined--Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Participants.................................... 5564 1 36/60 3344
Non-Participants................................ 3816 1 14.5/60 920
---------------------------------------------------------------
Totals...................................... 9380 .............. .............. 4264
----------------------------------------------------------------------------------------------------------------
(Note: reported and calculated numbers differ slightly due to rounding.)
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-23060 Filed 9-20-13; 8:45 am]
BILLING CODE 4140-01-P
