Pilot Program To Evaluate Proposed Proprietary Name Submissions; Public Meeting on Pilot Program Results Will Not Be Held, 62813-62814 [2011-26099]
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Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices
62813
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
10.75 ....................................................................................
1
3
3
10
30
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimated annual reporting
burden is based on CVM’s experience
over the past 3 years in handling formal
appeals for scientific disputes. The
number of respondents multiplied by
the number of responses per respondent
equals the total annual responses. The
average burden per response (in hours)
is based on discussions with industry
and may vary depending on the
complexity of the issue(s) involved and
the duration of the appeal process.
Dated: October 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–26132 Filed 10–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0281]
Pilot Program To Evaluate Proposed
Proprietary Name Submissions; Public
Meeting on Pilot Program Results Will
Not Be Held
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that it will not hold a public meeting to
discuss the results of a 2-year voluntary
pilot program that enabled participating
pharmaceutical firms to evaluate
proposed proprietary names and submit
the data generated from those
evaluations for FDA to review. FDA
anticipated holding a public meeting at
the end of fiscal year 2011 to discuss the
results of the pilot program, but the
Agency did not receive sufficient pilot
submissions to form a basis for
discussion. Interested parties may
submit to the docket any additional
comments on the pilot program. As
previously announced, FDA plans to
publish a draft guidance describing the
best test methods for proprietary name
evaluation.
DATES: Submit either electronic or
written comments by November 10,
2011.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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Submit electronic
comments on the pilot program or this
document to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Regarding human drug products: Carol
Holquist, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 4416, Silver Spring,
MD 20993–0002.
Regarding human biological products:
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration (HFM–17), 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
In Title I of the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), Congress
reauthorized and expanded the
Prescription Drug User Fee program for
fiscal years 2008 to 2012 (PDUFA IV). In
performance goals agreed to in
conjunction with the reauthorization of
PDUFA IV, FDA agreed to publish a
concept paper on and implement a pilot
program to enable pharmaceutical firms
to evaluate proposed proprietary names
and submit the data generated from
those evaluations to FDA for review.
(See IX.B at https://www.fda.gov/For
Industry/UserFees/PrescriptionDrug
UserFee/ucm119243.htm.).
In June 2008, FDA held a public
technical meeting (see 73 FR 27001,
May 12, 2008) to discuss a draft concept
paper describing the pilot program and
FDA’s thinking about how
pharmaceutical firms could participate
in the pilot program to evaluate
proposed proprietary names and submit
the data generated to FDA for review.
After considering comments from the
meeting and the public docket, FDA
announced the availability of the
concept paper entitled ‘‘PDUFA Pilot
Project Proprietary Name Review’’ in
the Federal Register of October 7, 2008
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
(73 FR 58604). As stated in the concept
paper, the goals of the pilot program
were to minimize the use of names that
are misleading or that are likely to lead
to medication errors, to make FDA’s
application review more efficient, and
to make regulatory decisions more
transparent.
In the Federal Register of October 1,
2009 (74 FR 50806), FDA announced the
opportunity for firms to register for and
submit data to the voluntary pilot
program. FDA stated that at the end of
fiscal year 2011, or after accruing 2
years experience with pilot program
submissions, the Agency would
evaluate the results to determine
whether the model of industry
conducting reviews, submitting the
results to FDA, and FDA reviewing the
data is feasible and whether it is a better
model than FDA conducting de novo
reviews of proprietary names. FDA
planned to hold a public meeting to
discuss the results of the pilot program
and recommended additions and/or
changes to methods based on the report
results. FDA also stated that, following
the meeting, FDA would publish draft
guidance on best test practices for
proprietary name review.
FDA began accepting requests to
participate in the pilot program on
October 1, 2009, and the pilot program
ended on September 30, 2011. Although
three applicants registered to participate
during the 2-year period, FDA received
only one complete submission for pilot
program review, which is not a
sufficient number to assess the
feasibility of industry conducting
reviews of proposed proprietary names.
Therefore, the public meeting that was
anticipated to occur at the end of fiscal
year 2011 to assess the pilot program for
evaluation of proposed proprietary
names will not be held because of
insufficient participation. The pilot
program docket (docket number FDA–
2008–N–0281) has remained open for
comment during the 2-year pilot
program, and FDA has invited
comments on human factor testing. In
lieu of a public meeting, interested
persons may submit any additional
comments to the docket. After the close
of the public comment period, FDA
intends to publish a draft guidance
E:\FR\FM\11OCN1.SGM
11OCN1
62814
Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices
describing the best test methods for
proprietary name evaluation.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding the pilot project or
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.
Dated: October 4, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–26099 Filed 10–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation; Notice of Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: Advisory Council on Blood Stem
Cell Transplantation (ACBSCT).
Date and Time: November 08, 2011, 10 am
to 4 pm EDT.
Place: The meeting will be via audio
conference call and Adobe Connect Pro.
Status: The meeting will be open to the
public.
Purpose: Pursuant to Public Law 109–129,
42 U.S.C. 274k (section 379 of the Public
Health Service Act, as amended,) the
Advisory Council on Blood Stem Cell
Transplantation (ACBSCT) advises the
Secretary of HHS and the Administrator,
HRSA, on matters related to the activities of
the C.W. Bill Young Cell Transplantation
Program (Program) and the National Cord
Blood Inventory (NCBI) Program.
Agenda: The Council will hear reports
from five ACBSCT Work Groups: Cord Blood
Bank Collections, Realizing the Potential of
Cord Blood, Scientific Factors Necessary to
Define a Cord Blood Unit as High Quality,
Cord Blood Thawing and Washing, and
Access to Transplantation. The Council also
will hear presentations and discussions,
which may include the following topics:
CAO study and report; FDA licensure and
unmet need.
The public can join the meeting by:
1. Calling Conference Phone Number: 888–
790–3527 and providing Participant Code:
8064893, for the audio portion, AND
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20:47 Oct 07, 2011
Jkt 226001
2. Connecting to the ACBSCT Adobe
Connect Pro Meeting for the visual portion
using the following URL: https://
hrsa.connectsolutions.com/acbsct/ (if the
link does not work, copy and paste it into
your browser). The conference call leader is
Patricia A. Stroup.
Call (301) 443–0437 or send an e-mail to
ptongele@hrsa.com if you are having trouble
connecting to the meeting site.
Participants should call no later than 9:45
am EDT in order for logistics to be set up.
If you have never attended an Adobe Pro
Connect Meeting, please test your connection
using the following URL: https://hrsa.connect
solutions.com/common/help/en/support/
meeting_test.htm.
For quick overview, please access: https://
www.adobe.com/go/connectpro_overview.
Those planning to participate are asked to
complete and submit an online registration
form by visiting our Web site at https://
www.ACBSCT.com and selecting the tab
titled ‘‘Registration.’’ Individuals with no
Internet access should request the
registration form by contacting Gabrielle
Kardolus at (301) 585–1261 or at
Gabrielle.Kardolus@luxcg.com and fax the
registration form to Gabrielle Kardolus at
(301) 585–7741. The registration deadline is
November 2, 2011. The next face-to-face
ACBSCT meeting is planned for Spring 2012.
Details regarding the next meeting will be
published in a subsequent Federal Register
notice.
Public Comment: Persons interested in
providing an oral presentation should submit
a written request, along with a copy of their
presentation to: Passy Tongele, DoT,
Healthcare Systems Bureau (HSB), Health
Resources and Services Administration
(HRSA), Room 12C–06, 5600 Fishers Lane,
Rockville, Maryland 20857 or e-mail:
ptongele@hrsa.gov. Requests should contain
the name, address, telephone number, e-mail
address, and any business or professional
affiliation of the person desiring to make an
oral presentation. Groups having similar
interests are requested to combine their
comments and present them through a single
representative. The allocation of time may be
adjusted to accommodate the level of
expressed interest. Persons who do not file
an advance request for a presentation, but
desire to make an oral statement, may
announce it at the time of the public
comment period. Public participation and
ability to comment will be limited to space
and time as it permits.
For Further Information Contact: Patricia
Stroup, Executive Secretary, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers Lane,
Room 12C–06, Rockville, Maryland 20857;
telephone (301) 443–1127.
Dated: October 3, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–26168 Filed 10–7–11; 8:45 am]
BILLING CODE 4165–15–P
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Frm 00060
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center For Research
Resources; 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Research Resources Special Emphasis Panel.
Date: November 9, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Rockville, 1750 Rockville
Pike, Rockville, MD 20852.
Contact Person: Martha F. Matocha, PhD,
Scientific Review Officer, Office of Review,
National Center for Research Resources,
National Institutes of Health, 6701
Democracy Blvd., 1 Democracy Plaza, Rm.
1070, Bethesda, MD 20892, 301–435–0813,
matocham@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure,
93.306, 93.333; 93.702, ARRA Related
Construction Awards., National Institutes of
Health, HHS)
Dated: October 4, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–26218 Filed 10–7–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; 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
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62813-62814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26099]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0281]
Pilot Program To Evaluate Proposed Proprietary Name Submissions;
Public Meeting on Pilot Program Results Will Not Be Held
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that it
will not hold a public meeting to discuss the results of a 2-year
voluntary pilot program that enabled participating pharmaceutical firms
to evaluate proposed proprietary names and submit the data generated
from those evaluations for FDA to review. FDA anticipated holding a
public meeting at the end of fiscal year 2011 to discuss the results of
the pilot program, but the Agency did not receive sufficient pilot
submissions to form a basis for discussion. Interested parties may
submit to the docket any additional comments on the pilot program. As
previously announced, FDA plans to publish a draft guidance describing
the best test methods for proprietary name evaluation.
DATES: Submit either electronic or written comments by November 10,
2011.
ADDRESSES: Submit electronic comments on the pilot program or this
document to https://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments
with the docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Regarding human drug products: Carol
Holquist, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4416, Silver
Spring, MD 20993-0002.
Regarding human biological products: Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration (HFM-
17), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-
827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
In Title I of the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85), Congress reauthorized and expanded the
Prescription Drug User Fee program for fiscal years 2008 to 2012 (PDUFA
IV). In performance goals agreed to in conjunction with the
reauthorization of PDUFA IV, FDA agreed to publish a concept paper on
and implement a pilot program to enable pharmaceutical firms to
evaluate proposed proprietary names and submit the data generated from
those evaluations to FDA for review. (See IX.B at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm.).
In June 2008, FDA held a public technical meeting (see 73 FR 27001,
May 12, 2008) to discuss a draft concept paper describing the pilot
program and FDA's thinking about how pharmaceutical firms could
participate in the pilot program to evaluate proposed proprietary names
and submit the data generated to FDA for review. After considering
comments from the meeting and the public docket, FDA announced the
availability of the concept paper entitled ``PDUFA Pilot Project
Proprietary Name Review'' in the Federal Register of October 7, 2008
(73 FR 58604). As stated in the concept paper, the goals of the pilot
program were to minimize the use of names that are misleading or that
are likely to lead to medication errors, to make FDA's application
review more efficient, and to make regulatory decisions more
transparent.
In the Federal Register of October 1, 2009 (74 FR 50806), FDA
announced the opportunity for firms to register for and submit data to
the voluntary pilot program. FDA stated that at the end of fiscal year
2011, or after accruing 2 years experience with pilot program
submissions, the Agency would evaluate the results to determine whether
the model of industry conducting reviews, submitting the results to
FDA, and FDA reviewing the data is feasible and whether it is a better
model than FDA conducting de novo reviews of proprietary names. FDA
planned to hold a public meeting to discuss the results of the pilot
program and recommended additions and/or changes to methods based on
the report results. FDA also stated that, following the meeting, FDA
would publish draft guidance on best test practices for proprietary
name review.
FDA began accepting requests to participate in the pilot program on
October 1, 2009, and the pilot program ended on September 30, 2011.
Although three applicants registered to participate during the 2-year
period, FDA received only one complete submission for pilot program
review, which is not a sufficient number to assess the feasibility of
industry conducting reviews of proposed proprietary names. Therefore,
the public meeting that was anticipated to occur at the end of fiscal
year 2011 to assess the pilot program for evaluation of proposed
proprietary names will not be held because of insufficient
participation. The pilot program docket (docket number FDA-2008-N-0281)
has remained open for comment during the 2-year pilot program, and FDA
has invited comments on human factor testing. In lieu of a public
meeting, interested persons may submit any additional comments to the
docket. After the close of the public comment period, FDA intends to
publish a draft guidance
[[Page 62814]]
describing the best test methods for proprietary name evaluation.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
pilot project or 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.
Dated: October 4, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-26099 Filed 10-7-11; 8:45 am]
BILLING CODE 4160-01-P
