Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine, 62812-62813 [2011-26132]
Download as PDF
<![CDATA[
62812
Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per response
Total hours
Experiment ...................
900
1
900
0.17 (10 min.) .................................................
153
Total .............................
........................
........................
........................
........................................................................
216
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Olsen, S., L. MacKinnon, J.S.
Goulding, et al., ‘‘Surveillance for
Foodborne Disease Outbreaks—
United States, 1993 to 1997,’’
Morbidity and Mortality Weekly
Report, vol. 49, pp. 1–51, 2000.
2. ‘‘FDA 101: Product Recalls—From
First Alert to Effectiveness Checks,’’
(https://www.fda.gov/ForConsumers/
ConsumerUpdates/
ucm049070.htm).
3. Calvin, L., ‘‘Outbreak Linked to
Spinach Forces Reassessment of
Food Safety Practices,’’ Amber
Waves, vol. 5, pp. 24–31, 2007.
4. Lucier, G. and R. Dettmann,
‘‘Vegetables and Melons Outlook: A
Report From the United States
Department of Agriculture,
Economic Research Service,’’ VGS–
327, June 26, 2008.
Dated: October 4, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–26131 Filed 10–7–11; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Appeals of Science-Based Decisions
Above the Division Level at the Center
for Veterinary Medicine—21 CFR Part
10.75 (OMB Control Number 0910–
0566)—Extension
[Docket No. FDA–2011–N–0509]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Appeals of
Science-Based Decisions Above the
Division Level at the Center for
Veterinary Medicine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
10, 2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0566. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
20:47 Oct 07, 2011
Jkt 226001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Respondents: Respondents to this
collection of information are applicants
that wish to submit a request for review
of a scientific dispute.
The Center for Veterinary Medicine’s
Guidance for Industry #79 ‘‘Dispute
Resolution Procedures for ScienceBased Decisions on Products Regulated
by the Center for Veterinary Medicine’’
describes the process by which the
Center for Veterinary Medicine (CVM)
formally resolves disputes relating to
scientific controversies. A scientific
controversy involves issues concerning
a specific product regulated by CVM
related to matters of technical expertise
and requires specialized education,
training, or experience to be understood
and resolved. Further, the guidance
details information on how the Agency
intends to interpret and apply
provisions of the existing regulations
regarding internal Agency review of
decisions. In addition, the guidance
outlines the established procedures for
persons who are sponsors, applicants, or
manufacturers, for animal drugs or other
products regulated by CVM, that wish to
submit a request for review of a
scientific dispute. When a sponsor,
applicant, or manufacturer has a
scientific disagreement with a written
decision by CVM, they may submit a
request for a review of that decision by
following the established Agency
channels of supervision for review.
In the Federal Register of July 13,
2011 (76 FR 41264), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\11OCN1.SGM
11OCN1
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:
VerDate Mar<15>2010
20:47 Oct 07, 2011
Jkt 226001
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
]]>Agencies
[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62812-62813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26132]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0509]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Appeals of Science-
Based Decisions Above the Division Level at the Center for Veterinary
Medicine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 10, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0566.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Appeals of Science-Based Decisions Above the Division Level at the
Center for Veterinary Medicine--21 CFR Part 10.75 (OMB Control Number
0910-0566)--Extension
Respondents: Respondents to this collection of information are
applicants that wish to submit a request for review of a scientific
dispute.
The Center for Veterinary Medicine's Guidance for Industry
79 ``Dispute Resolution Procedures for Science-Based Decisions
on Products Regulated by the Center for Veterinary Medicine'' describes
the process by which the Center for Veterinary Medicine (CVM) formally
resolves disputes relating to scientific controversies. A scientific
controversy involves issues concerning a specific product regulated by
CVM related to matters of technical expertise and requires specialized
education, training, or experience to be understood and resolved.
Further, the guidance details information on how the Agency intends to
interpret and apply provisions of the existing regulations regarding
internal Agency review of decisions. In addition, the guidance outlines
the established procedures for persons who are sponsors, applicants, or
manufacturers, for animal drugs or other products regulated by CVM,
that wish to submit a request for review of a scientific dispute. When
a sponsor, applicant, or manufacturer has a scientific disagreement
with a written decision by CVM, they may submit a request for a review
of that decision by following the established Agency channels of
supervision for review.
In the Federal Register of July 13, 2011 (76 FR 41264), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 62813]]
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
