Psychopharmacologic Drugs Advisory Committee; Amendment of Notice, 2924-2925 [E8-726]
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2924
Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Notices
Dated: January 3, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–675 Filed 1–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0390]
User Fee Program for Advisory Review
of Direct-to-Consumer Television
Advertisements for Prescription Drug
and Biological Products; Program Will
Not Be Implemented
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
notice to inform companies that the
Direct-to-Consumer (DTC) television
advertisement user fee program will not
commence because the necessary user
fees for the program were not ‘‘provided
in advance in appropriations Acts’’ as
required by the Food and Drug
Administration Amendments Act of
2007 (FDAAA) and the previously
issued notice establishing user fee rates
for the program for fiscal year (FY) 2008
is being withdrawn.
FOR FURTHER INFORMATION CONTACT:
Wayne Amchin, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 1454,
Silver Spring, MD 20993–0002, 301–
796–1200, FAX: 301–796–9878, e-mail:
dtcp@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
September 27, 2007, the President
signed into law FDAAA (Public Law
110–85). Title I of FDAAA reauthorized
the Prescription Drug User Fee Act for
FYs 2008 to 2012. In addition, Title I
created new section 736A of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 379h–1), which authorized a
new and separate user fee program for
the advisory review of DTC prescription
drug television advertisements. The
DTC user fee program would have been
available to companies interested in
voluntarily submitting to FDA for
advisory review a DTC television
advertisement, as defined in section
736A(h)(4) of the act. FDAAA provided,
however, that if FDA fails to receive at
least $11,250,000 in advisory review
fees and operating reserve fees
combined by 120 days after the
legislation is enacted (i.e., by January
VerDate Aug<31>2005
17:55 Jan 15, 2008
Jkt 214001
25, 2008), the program shall not
commence (section 736A(f)(1) of the
act). FDAAA also provided that the fees
authorized for the DTC program ‘‘shall
be collected and available for obligation
only to the extent and in the amount
provided in advance in appropriations
Acts.’’ (section 736A(g)(1) of the act).
On December 26, 2007, the President
signed the Consolidated Appropriations
Act, 2008 (Public Law 110–161). The
law does not appropriate user fee funds
for the voluntary review of DTC
television advertisements. As a result,
under section 736A(g)(1) of the act, FDA
does not have the authority to collect
and spend user fees for this purpose.
Furthermore, as noted previously,
section 736A(f)(1) of the act provides
that if FDA has not collected at least
$11,250,000 in advisory review fees and
operating reserve fees combined by 120
days after the legislation is enacted (i.e.,
by January 25, 2008), the program shall
not commence. Therefore, no invoices
will be sent. Advertisements voluntarily
submitted for FDA review will be
reviewed in as timely a manner as
resources permit. In addition, FDA is
withdrawing the previously issued
Federal Register notice establishing the
user fee rates for this program for FY
2008 (72 FR 70334, December 11, 2007).
Dated: January 10, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–740 Filed 1–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic Drugs Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the
Psychopharmacologic Drugs Advisory
Committee. This meeting was
announced in the Federal Register of
December 19, 2007 (72 FR 71923). The
amendment is being made to reflect
changes in the Location, Contact Person,
and Procedure portions of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Diem-Kieu Ngo, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630
Fishers Lane, rm. 1093), Rockville, MD
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
20857, 301–827–7001, FAX: 301–827–
6776, e-mail: diem.ngo@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington DC area), code
3014512544. Please call the Information
Line for up-to-date information on this
meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of December 19, 2007,
FDA announced that a meeting of the
Psychopharmacologic Drugs Advisory
Committee would be held on February
6, 2008.
On page 71923, in the third column,
the Location portion of the document is
changed to read as follows:
Location: Crowne Plaza/Silver Spring,
Kennedy Ballrooms, 8777 Georgia Ave.,
Silver Spring, MD. The hotel telephone
number is 301–589–0800.
On page 71923, in the third column,
the first sentence of the Contact Person
portion of the document is changed to
read as follows:
Contact Person: Diem-Kieu Ngo,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane, (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
diem.ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544.
On page 71924, in the first column,
the first paragraph of the Procedure
portion of the document is changed to
read as follows:
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 January 18, 2008.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. and 2:30 p.m. Those desiring
to make 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 January 10, 2008. 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
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16JAN1
2925
Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Notices
regarding their request to speak by
January 11, 2008.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 10, 2008.
Randall W. Lutter,
Assistant Commissioner for Policy.
[FR Doc. E8–726 Filed 1–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Quality of Life
Outcomes in Neurological Disorders
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Neurological Disorders and
Stroke (NINDS), the National Institutes
of Health (NIH) has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on September 24, 2007, page
number 54269 and allowed 60 days for
public comment. One public comment
was received; also received were one
request for the data collection plans and
proposed instruments and a request for
information on a related Web site. The
purpose of this notice is to allow an
additional 30 days for public comment.
The 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.
Proposed Collection: Title: Quality of
Life Outcomes in Neurological
Disorders; Type of Information
Collection Request: New; Form Number:
NA; Need and Use of Information
Collection: In order to improve outcome
Number of
respondents
Type of respondents
measurement in clinical trials of
neurological conditions, NINDS is
developing a health-related quality of
life (HRQL) measurement system for
major neurological diseases that affect
the United States population. This
measurement system must be consistent
enough across the selected conditions to
allow for cross-disease comparison, and
yet flexible enough to capture
condition-specific HRQL issues. The
primary end users of this measurement
system will be clinical trialists and
other clinical neurology researchers;
however the measurement system will
also be appropriate for clinical practice.
The proposed information collection
will support psychometric testing of
HRQL item banks and testing of Spanish
translation of the final questionnaires.
Frequency of Response: Once; Affected
Public: Individuals; Type of
Respondent: Adults and children. The
annual reporting burden is shown in the
following table. There are no Capital
Costs, Operating Costs or Maintenance
Costs to report.
Frequency of
response
Average time
per response
Annual hour
burden
6,000
3,000
1
1
0.5
0.5
3,000
1,500
Totals ........................................................................................................
jlentini on PROD1PC65 with NOTICES
Adults ...............................................................................................................
Children ............................................................................................................
9,000
........................
........................
4,500
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
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, New Executive
VerDate Aug<31>2005
17:55 Jan 15, 2008
Jkt 214001
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Claudia Moy, Program Director, Clinical
Trials Group, NINDS, NIH,
Neuroscience Center, 6001 Executive
Boulevard, Room 2214, Bethesda, MD
20892, or call non-toll-free number 301–
496–2789 or e-mail your request,
including your address to:
<moyc@ninds.nih.gov>.
Comments 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.
Dated: December 20, 2007.
Joellen Austin Harper,
Executive Officer, NINDS, National Institutes
of Health.
[FR Doc. E8–606 Filed 1–15–08; 8:45 am]
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PO 00000
Frm 00045
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Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Longitudinal
Investigation of Fertility and the
Environment Study
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval. This is a request
for renewal of an information collection
request that was approved (OMB
Clearance 0925–0543) following
publication in the Federal Register on
January 9, 2004, page 1589 and
December 2, 2004, page 70153.
Proposed Collection: Title:
Longitudinal Investigation of Fertility
and the Environment Study. Type of
E:\FR\FM\16JAN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Notices]
[Pages 2924-2925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-726]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic Drugs Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Psychopharmacologic Drugs Advisory
Committee. This meeting was announced in the Federal Register of
December 19, 2007 (72 FR 71923). The amendment is being made to reflect
changes in the Location, Contact Person, and Procedure portions of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Diem-Kieu Ngo, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail:
diem.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington DC area), code 3014512544.
Please call the Information Line for up-to-date information on this
meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 19,
2007, FDA announced that a meeting of the Psychopharmacologic Drugs
Advisory Committee would be held on February 6, 2008.
On page 71923, in the third column, the Location portion of the
document is changed to read as follows:
Location: Crowne Plaza/Silver Spring, Kennedy Ballrooms, 8777
Georgia Ave., Silver Spring, MD. The hotel telephone number is 301-589-
0800.
On page 71923, in the third column, the first sentence of the
Contact Person portion of the document is changed to read as follows:
Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857, 301-827-7001, FAX: 301-827-6776, e-mail: diem.ngo@fda.hhs.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512544.
On page 71924, in the first column, the first paragraph of the
Procedure portion of the document is changed to read as follows:
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
January 18, 2008. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. Those desiring to make
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 January 10, 2008. 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
[[Page 2925]]
regarding their request to speak by January 11, 2008.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: January 10, 2008.
Randall W. Lutter,
Assistant Commissioner for Policy.
[FR Doc. E8-726 Filed 1-15-08; 8:45 am]
BILLING CODE 4160-01-S
