Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 45198-45199 [2014-18304]
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45198
Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Recall
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Firm Initiated Recall (21 CFR 7.46) and Recall Communications (21 CFR 7.49) ...................................................
Recall Status Reports (21 CFR 7.53) ..................................
Termination of a Recall (21 CFR 7.55(b)) ...........................
3,801
3,801
3,801
1
13
1
3,801
49,413
3,801
25
10
10
95,025
494,130
38,010
Total ..............................................................................
........................
........................
........................
........................
627,165
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
I. Total Annual Reporting
tkelley on DSK3SPTVN1PROD with NOTICES
A. Firm Initiated Recall and Recall
Communications
Request firms voluntarily remove or
correct foods and drugs (human or
animal), cosmetics, medical devices,
biologics, and tobacco to immediately
notify the appropriate FDA District
Office of such actions. The firm is to
provide complete details of the recall
reason, risk evaluation, quantity
produced, distribution information,
firms’ recall strategy and a contact
official as well as requires firms to
notify their direct accounts of the recall
and to provide recipients with a ready
means of reporting to the recalling firm.
Under these portions of the collection of
information, the Agency estimates it
will receive 3,801 responses annually
based on the average number of recalls
over the last 3 fiscal years. The number
of responses multiplied by the number
of respondents equal 3,801. The average
burden hours of 25 multiplied by the
total number of annual responses equal
95,025. The average burden hour person
response was 30 and has decreased by
5.
B. Recall Status Reports
Request that recalling firms provide
periodic status reports so FDA can
ascertain the progress of the recall. This
request only applies to firms with active
recalls, and is estimated to be reported
every 2 to 4 weeks. This collection of
information will generate approximately
3,801 responses annually, based on the
average number of recalls over the last
3 fiscal years 11,403. The number of
respondents multiplied by the number
of responses per respondents (13) equal
a total number of annual responses of
49,413. The total number of responses
49,413 with an average burden hours of
10 per response equal a total of 494,130
total hours.
C. Termination of a Recall
Provide the firms an opportunity to
request in writing that FDA end the
recall. The Agency estimates it will
receive 3,801 responses annually based
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18:11 Aug 01, 2014
Jkt 232001
on the average number of terminations
over the past 3 fiscal years. The total
annual responses of 3,801 multiplied by
the average burden hours of 10 per
response equal a total number of hours
of 38,010.
II. Hours per Response Estimates
FDA has no information which would
allow it to make a calculated estimate
on the hours per response burden to
FDA regulated firms to conduct recalls.
Variables in the type of products, the
quantity and level of distribution and
the various circumstances of recall
notifications could cause the hours per
response to vary significantly. The best
guesstimate of average burden hours per
response from previous information
collection request reports are utilized
again for the current estimates on
burden hours per response.
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18322 Filed 8–1–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Endocrinologic
and Metabolic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
PO 00000
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Date and Time: The meeting will be
held on September 11, 2014, from 8 a.m.
to 5 p.m.
Location: The Marriott Inn and
Conference Center, University of
Maryland University College, Potomac
Ballroom, 3501 University Blvd. East,
Hyattsville, MD 20783. The conference
center’s telephone number is 301–985–
7300.
Contact Person: Karen AbrahamBurrell, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2147, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email: EMDAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
the safety and efficacy of new drug
application (NDA) 206321, liraglutide
for injection, sponsored by Novo
Nordisk, Inc. The proposed indication
for liraglutide is as an adjunct to a
reduced-calorie diet and increased
physical activity for chronic weight
management in adult patients with an
initial body mass index (BMI) of 30
kilograms per square meter (kg/m2) or
greater, or with an initial BMI of 27 kg/
m2 or greater in the presence of at least
one weight-related comorbidity.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
E:\FR\FM\04AUN1.SGM
04AUN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Notices
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 27, 2014.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before August
19, 2014. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 20, 2014.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Karen
Abraham-Burrell at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
VerDate Mar<15>2010
17:28 Aug 01, 2014
Jkt 232001
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18304 Filed 8–1–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Tribal Management Grant Program;
Correction
Indian Health Service, HHS.
Notice; correction.
AGENCY:
ACTION:
The Indian Health Service
published a document in the Federal
Register on July 3, 2014, for the FY 2014
Tribal Management Grant Program
Announcement. Key information
pertaining to Funding Restrictions was
omitted.
FOR FURTHER INFORMATION CONTACT: Ms.
Patricia Spotted Horse, Program
Analyst, Office of Direct Service and
Contracting Tribes, Indian Health
Service, 801 Thompson Avenue, Suite
220, Rockville, MD 20852, Telephone
(301) 443–1104. (This is not a toll-free
number.)
SUMMARY:
Corrections
In the Federal Register of July 3,
2014, in FR Doc. 2014–15595, on page
38043, in the second column, under the
heading 5. Funding Restrictions after
the fourth bullet, the following language
regarding Restrictions should be added:
• The TMG may not be used to
support recurring operational programs
or to replace existing public and private
resources. Funding received under a
recurring Public Law 93–638 contract
cannot be totally supplanted or totally
replaced. Exception is allowed to charge
a portion or percentage of salaries of
existing staff positions involved in
implementing the TMG grant, if
applicable. However, this percentage of
TMG funding must reflect
supplementation of funding for the
project not supplantation of existing
ISDEAA contract funds.
Supplementation is ‘‘adding to a
program’’ whereas supplantation is
‘‘taking the place of’’ funds. An entity
cannot use the TMG funds to supplant
the ISDEAA contract or recurring
funding.
• Ineligible Project Activities—The
inclusion of the following projects or
activities in an application will render
the application ineligible.
Æ Planning and negotiating activities
associated with the intent of a Tribe to
enter the IHS Self-Governance Project. A
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45199
separate grant program is administered
by the IHS for this purpose. Prospective
applicants interested in this program
should contact Mrs. Anna Johnson,
Program Analyst, Office of Tribal SelfGovernance, Indian Health Service,
Reyes Building, 801 Thompson Avenue,
Suite 240, Rockville, Maryland 20852,
(301) 443–7821, and request information
concerning the ‘‘Tribal Self-Governance
Program Planning Cooperative
Agreement Announcement’’ or the
‘‘Negotiation Cooperative Agreement
Announcement.’’
Æ Projects related to water, sanitation,
and waste management.
Æ Projects that include direct patient
care and/or equipment to provide those
medical services to be used to establish
or augment or continue direct patient
clinical care. Medical equipment that is
allowable under the Special Diabetes
Grant Program is not allowable under
the TMG Program.
Æ Projects that include recruitment
efforts for direct patient care services.
Æ Projects that include long-term care
or provision of any direct services.
Æ Projects that include tuition, fees,
or stipends for certification or training
of staff to provide direct services.
Æ Projects that include pre-planning,
design, and planning of construction for
facilities, including activities relating to
program justification documents.
Æ Projects that propose more than one
project type. Refer to Section II, ‘‘Award
Information,’’ specifically ‘‘Eligible
TMG Project Types, Maximum Funding
Levels and Project Periods’’ for more
information. An example of a proposal
with more than one project type that
would be considered ineligible may
include the creation of a strategic health
plan (defined by TMG as a planning
project type) and improving third-party
billing structures (defined by TMG as a
health management structure project
type). Multi-year applications that
include in the first year planning,
evaluation, or feasibility activities with
the remainder of the project years
addressing management structure are
also deemed ineligible.
• Other Limitations—A current TMG
recipient cannot be awarded a new,
renewal, or competing continuation
grant for any of the following reasons:
Æ The grantee will be administering
two TMGs at the same time or have
overlapping project/budget periods;
Æ The current project is not
progressing in a satisfactory manner;
Æ The current project is not in
compliance with program and financial
reporting requirements; or
Æ The applicant has an outstanding
delinquent Federal debt. No award shall
be made until either:
E:\FR\FM\04AUN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 149 (Monday, August 4, 2014)]
[Notices]
[Pages 45198-45199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18304]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 11, 2014, from
8 a.m. to 5 p.m.
Location: The Marriott Inn and Conference Center, University of
Maryland University College, Potomac Ballroom, 3501 University Blvd.
East, Hyattsville, MD 20783. The conference center's telephone number
is 301-985-7300.
Contact Person: Karen Abraham-Burrell, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2147, Silver Spring, MD 20993-0002, 301-796-9001, FAX:
301-847-8533, email: EMDAC@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: The committee will discuss the safety and efficacy of new
drug application (NDA) 206321, liraglutide for injection, sponsored by
Novo Nordisk, Inc. The proposed indication for liraglutide is as an
adjunct to a reduced-calorie diet and increased physical activity for
chronic weight management in adult patients with an initial body mass
index (BMI) of 30 kilograms per square meter (kg/m\2\) or greater, or
with an initial BMI of 27 kg/m\2\ or greater in the presence of at
least one weight-related comorbidity.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will
[[Page 45199]]
be made publicly available at the location of the advisory committee
meeting, and the background material will be posted on FDA's Web site
after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee meeting link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 27, 2014. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before August 19, 2014. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by August 20, 2014.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Karen Abraham-
Burrell at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18304 Filed 8-1-14; 8:45 am]
BILLING CODE 4164-01-P
