Pediatric Advisory Committee; Notice of Meeting, 46304-46305 [2011-19481]
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Federal Register / Vol. 76, No. 148 / Tuesday, August 2, 2011 / Notices
erowe on DSK5CLS3C1PROD with NOTICES
guidance, FDA also announced that it
no longer intends to exercise
enforcement discretion with respect to
the IND and biologics license
application (BLA) requirements, and the
phase-in implementation period for IND
and license application requirements
will end as of October 20, 2011. FDA
also encouraged sponsors to send in
applications as soon as possible to allow
sufficient time for review, comment,
and resubmission as needed to complete
all actions by the end of this 2-year
period. FDA continues to encourage
potential sponsors to submit new
protocols as needed to their existing
INDs, or new INDs if needed, or BLAs
as soon as possible, so that FDA may
work with them to ensure that the
protocols are in effect or that the BLAs
are approved, if appropriate, by the end
of the phase-in implementation period.
We acknowledge that there will be
cord blood banks that are not able to
achieve licensure by October 20, 2011.
Furthermore, we acknowledge that
should we approve a bank’s BLA, our
approval may not include all the HPC–
Cs in that bank’s inventory. We note
that if a bank is unable to obtain a BLA
by October 20, 2011, or if its BLA does
not include all the HPC–Cs in that
bank’s inventory, its unlicensed units
may be released for use only under an
IND.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. 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 satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information 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
part 312 have been approved under
OMB control number 0910–0014; 21
CFR Part 56 have been approved under
OMB control number 0910–0130; 21
CFR Part 1271 have been approved
under OMB control number 0910–0543;
and FDA Form 1571 has been approved
under OMB control number 0910–0014.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
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comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: July 26, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–19483 Filed 8–1–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Pediatric 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: Pediatric
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 Thursday, September 22, 2011,
from 2 p.m. to 6:30 p.m. and on Friday,
September 23, 2011, from 8 a.m. to 5:30
p.m.
Location: Hilton Washington DC
North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
Contact Person: Walter Ellenberg,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993–0002, 301–
796–0885, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), and follow the prompts to the
desired center or product area. Please
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call the Information Line for up-to-date
information on this meeting. 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 and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On Thursday, September 22,
2011, the Pediatric Advisory Committee
will meet to discuss pediatric-focused
safety reviews, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the Pediatric Research
Equity Act (Pub. L. 108–155), for Fluarix
(influenza virus vaccine), Afluria
(influenza virus vaccine), and Abilify
(aripiprazole). There will also be an
update on a study jointly funded by the
Agency for Healthcare Research and
Quality (AHRQ) and FDA on
antipsychotic use and metabolic effects
in children.
On Friday, September 23, 2011, the
Pediatric Advisory Committee will meet
to discuss pediatric-focused safety
reviews, as mandated by the Best
Pharmaceuticals for Children Act and
the Pediatric Research Equity Act, for
Akten (lidocaine hydrochloride), Famvir
(famciclovir), Levaquin (levofloxacin),
Navstel (balanced salt ophthalmic
solution with hypromellose, dextrose,
and glutathione), Retrovir (zidovudine),
Topamax (topiramate), Triesence
(triamcinolone acetonide injectable
suspension), Videx EC (didanosine),
Ziagen (abacavir sulfate), and Zomig
Nasal Spray (zolmitriptan). There will
be an informational update on Kaletra
(lopinavir/ritonavir) oral solution and
tablets.
As mandated by the Food and Drug
Administration Amendments Act, Title
III, Pediatric Medical Device Safety and
Improvement Act of 2007 (Pub. L. 110–
85), the committee will discuss the
safety of and profit-making waiver for
the pediatric humanitarian device,
Melody Transcatheter Pulmonary Valve
and Ensemble Delivery System.
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
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.
E:\FR\FM\02AUN1.SGM
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Federal Register / Vol. 76, No. 148 / Tuesday, August 2, 2011 / Notices
erowe on DSK5CLS3C1PROD with NOTICES
htm. Scroll down to the appropriate
advisory committee 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 Friday, September
16, 2011. Oral presentations from the
public will be scheduled between
approximately 2 p.m. and 3 p.m on
Friday, September 23, 2011. 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 Friday, September 2, 2011.
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
Tuesday, September 6, 2011.
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 notify Walter
Ellenberg 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/Advisory
Committees/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 28, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–19481 Filed 8–1–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Eligibility Criteria for Sites Recruiting
National Health Service Corps
Scholars
Health Resources and Services
Administration, HHS.
ACTION: General notice.
AGENCY:
The Health Resources and
Services Administration (HRSA)
announces the eligibility criteria,
including their Health Professional
Shortage Area (HPSA) scores, for
entities that are seeking to recruit
National Health Service Corps (NHSC)
scholarship recipients (Corps Personnel,
Corps members) during the period July
1, 2011, through June 30, 2012. A
searchable database that specifies all
currently approved NHSC service sites
is posted on the NHSC Web site at
https://datawarehouse.hrsa.gov/HGDW
Reports/OneClickRptFilter.
aspx?rptName=NHSCAppSiteList&
rptFormat=HTML3.2. This database can
be searched by State and can be utilized
to determine which entities are eligible
to receive assignment of Corps members
who are participating in the NHSC
Scholarship Program based on the
threshold HPSA score set forth below.
Please note that entities on this list may
or may not have current job
opportunities for NHSC scholars.
Further, not all vacancies associated
with sites on the list described below
will be for Corps members, but could be
for NHSC Scholarship Program
participants serving their obligation
through the Private Practice Option.
SUMMARY:
Eligible HPSAs and Entities
To be eligible to receive assignment of
Corps personnel, entities must: (1) Have
a current HPSA status of ‘‘designated’’
by the Office of Shortage Designation,
Bureau of Health Professions, HRSA; (2)
not deny requested health care services,
or discriminate in the provision of
services to an individual because the
individual is unable to pay for the
services or because payment for the
services would be made under
Medicare, Medicaid, or the Children’s
Health Insurance Program (CHIP); (3)
enter into an agreement with the State
agency that administers Medicaid and
CHIP, accept assignment under
Medicare, see all patients regardless of
their ability to pay and post such policy,
and use and post a discounted fee plan;
and (4) be determined by the Secretary
to have (a) A need and demand for
health manpower in the area; (b)
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46305
appropriately and efficiently used Corps
members assigned to the entity in the
past; (c) general community support for
the assignment of Corps members; (d)
made unsuccessful efforts to recruit; (e)
a reasonable prospect for sound fiscal
management by the entity with respect
to Corps members assigned there; and (f)
demonstrated a willingness to support
and facilitate mentorship, professional
development, and training opportunities
for Corps members. Priority in
approving applications for assignment
of Corps members goes to sites that (1)
Provide primary medical care, mental
health, and/or oral health services to a
primary medical care, mental health, or
dental HPSA of greatest shortage,
respectively; (2) are part of a system of
care that provides a continuum of
services, including comprehensive
primary health care and appropriate
referrals or arrangements for secondary
and tertiary care; (3) have a documented
record of sound fiscal management; and
(4) will experience a negative impact on
its capacity to provide primary health
services if a Corps members is not
assigned to the entity.
Entities that receive assignment of
Corps personnel must assure that (1)
The position will permit the full scope
of practice and that the clinician meets
the credentialing requirements of the
State and site; and (2) the Corps member
assigned to the entity is engaged in the
requisite amount of clinical practice, as
defined below, to meet his or her service
obligation:
Full-Time Clinical Practice
‘‘Full-time clinical practice’’ is
defined as a minimum of 40 hours per
week for at least 45 weeks per service
year. The 40 hours per week may be
compressed into no less than 4 work
days per week, with no more than 12
hours of work to be performed in any
24-hour period. Time spent on-call does
not count toward the full-time service
obligation.
For all health professionals, except as
noted below, at least 32 of the minimum
40 hours per week must be spent
providing direct patient care or teaching
in the outpatient ambulatory care
setting(s) at the NHSC-approved service
site(s) during normally scheduled office
hours. The remaining 8 hours per week
must be spent providing clinical
services for patients or teaching in the
approved practice site(s), providing
clinical services in alternative settings
as directed by the approved practice
site(s), or performing practice-related
administrative activities. Teaching
activities at the approved service site
shall not exceed 8 hours of the
minimum 40 hours per week, unless the
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]]>Agencies
[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Pages 46304-46305]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19481]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Pediatric 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: Pediatric 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 Thursday, September 22,
2011, from 2 p.m. to 6:30 p.m. and on Friday, September 23, 2011, from
8 a.m. to 5:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
Contact Person: Walter Ellenberg, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993-0002, 301-796-0885, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting. 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 and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On Thursday, September 22, 2011, the Pediatric Advisory
Committee will meet to discuss pediatric-focused safety reviews, as
mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109)
and the Pediatric Research Equity Act (Pub. L. 108-155), for Fluarix
(influenza virus vaccine), Afluria (influenza virus vaccine), and
Abilify (aripiprazole). There will also be an update on a study jointly
funded by the Agency for Healthcare Research and Quality (AHRQ) and FDA
on antipsychotic use and metabolic effects in children.
On Friday, September 23, 2011, the Pediatric Advisory Committee
will meet to discuss pediatric-focused safety reviews, as mandated by
the Best Pharmaceuticals for Children Act and the Pediatric Research
Equity Act, for Akten (lidocaine hydrochloride), Famvir (famciclovir),
Levaquin (levofloxacin), Navstel (balanced salt ophthalmic solution
with hypromellose, dextrose, and glutathione), Retrovir (zidovudine),
Topamax (topiramate), Triesence (triamcinolone acetonide injectable
suspension), Videx EC (didanosine), Ziagen (abacavir sulfate), and
Zomig Nasal Spray (zolmitriptan). There will be an informational update
on Kaletra (lopinavir/ritonavir) oral solution and tablets.
As mandated by the Food and Drug Administration Amendments Act,
Title III, Pediatric Medical Device Safety and Improvement Act of 2007
(Pub. L. 110-85), the committee will discuss the safety of and profit-
making waiver for the pediatric humanitarian device, Melody
Transcatheter Pulmonary Valve and Ensemble Delivery System.
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 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.
[[Page 46305]]
htm. Scroll down to the appropriate advisory committee 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
Friday, September 16, 2011. Oral presentations from the public will be
scheduled between approximately 2 p.m. and 3 p.m on Friday, September
23, 2011. 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 Friday, September 2, 2011. 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 Tuesday, September 6, 2011.
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 notify Walter Ellenberg 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 28, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19481 Filed 8-1-11; 8:45 am]
BILLING CODE 4160-01-P
