Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Final Guidance for Industry on Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine, 12699-12700 [05-5040]
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Federal Register / Vol. 70, No. 49 / Tuesday, March 15, 2005 / Notices
review and decision on issues that arise
during inspections:
• Tier-one of the dispute resolution
process provides a mechanism to raise
scientific or technical issues to the ORA
and center levels,
• Tier-two of the dispute resolution
process provides a mechanism to raise
scientific or technical issues to the
agency’s DR Panel.
The guidance also covers the following
topics:
• The suitability of certain issues for
the formal dispute resolution process,
including examples of some issues with
a discussion of their appropriateness for
the dispute resolution process,
• Instructions on how to submit
requests for formal dispute resolution
and a list of the supporting information
that should accompany these requests,
and
• Public availability of decisions
reached during the dispute resolution
process to promote consistent
application and interpretation of drug
quality-related regulations.
Dated: March 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–5027 Filed 3–14–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D–0167]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Final Guidance for
Industry on Dispute Resolution
Procedures for Science-Based
Decisions on Products Regulated by
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 April 14,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
VerDate jul<14>2003
15:31 Mar 14, 2005
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including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane, rm.
4B–41, Rockville, MD 20857, 301–827–
1472.
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.
Title: Dispute Resolution Procedures
for Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine
Description: FDA is issuing a final
guidance on the Center for Veterinary
Medicine (CVM) process for formally
resolving disputes relating to scientific
controversies. The final guidance
describes procedures for formally
appealing such disputes. The final
guidance provides information on how
the agency intends to interpret and
apply provisions of the existing
regulations regarding internal agency
review of decisions (§ 10.75 (21 CFR
10.75)). In a final rule issued in the
Federal Register of November 18, 1998
(63 FR 63978), FDA amended § 10.75 to
reflect the provisions of FDAMA. This
final guidance document outlines the
recommended procedures for persons
who are applicants for approval of
animal drugs or other products
regulated by CVM who wish to submit
a request for review of a scientific
dispute.
The final guidance recommends a
procedure whereby applicants first seek
review through the supervisory chain of
command. If the issue is not resolved at
the supervisor’s level, the interested
person may request in writing that the
matter be reviewed at the next higher
supervisory level. This process may
continue throughout the agency’s entire
supervisory chain of command through
CVM and up to the level of the
Commissioner of Food and Drugs
(Commissioner). At each level of review
(Division, Office Director, Deputy
Center Director, and Center Director
levels) CVM recommends that the
applicant identify the information in the
administrative file upon which the
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12699
request is based. If the appeal contains
new information not previously
contained in the administrative file, the
matter will, in accordance with 21 CFR
10.75(d), be returned to the appropriate
lower level in CVM for reevaluation
based on that new information. After the
applicant has appealed the decision
through the supervisory chain of
command, they may request review
through an ad hoc appeals committee or
review by the Veterinary Medicine
Advisory Committee (VMAC) in writing
to the CVM Ombudsman. If the
applicant seeks review by the Ad Hoc
Committee, the Chair should provide
them the opportunity to submit written
arguments to the Committee. The
applicant may submit a letter appealing
the Ad Hoc Committee’s decision to the
CVM Director and then to the
Commissioner. CVM recommends that
persons filing a request for review by
VMAC provide the CVM Ombudsman
with a concise summary of the scientific
issue in dispute, including a summary
of the particular FDA action or decision
to which the requesting party objects,
the results of all efforts that have been
made to resolve the dispute to date, and
a clear articulated summary of the
arguments and relevant data and
information.
The information collected will form
the basis for resolving the dispute
between the requester and FDA. The
likely respondents to this collection of
information are applicants for approval
of animal drugs or other products
regulated by CVM who have a scientific
dispute with FDA and who request a
review of the matter.
Based on FDA’s experience with
dispute resolution, the agency expects
that most persons seeking formal
dispute resolution will have gathered
the materials during any previous efforts
to resolve the dispute with the agency.
CVM considered the number and
substance of similar appeals made to
FDA in recent years under Guide
1240.3130 to arrive at numbers reflected
in table 1 of this document. Guidance
#79 will supercede Guide 1240.3130
and CVM will eliminate the guide from
the P & P Manual.
In the Federal Register of May 19,
2003 (68 FR 27094), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\15MRN1.SGM
15MRN1
12700
Federal Register / Vol. 70, No. 49 / Tuesday, March 15, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Guidance
1 There
1
Dated: March 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–5040 Filed 3–14–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
Food and Drug Administration,
HHS.
ACTION:
Total Annual
Responses
2
Hours
per Respondent
2
Total Hours
30
60
are no capital costs or operating and maintenance costs associated with this collection of information.
The use of VMAC for resolving
scientific disputes represents a new
process for CVM. Although the
procedures for requesting dispute
resolution by a scientific advisory
committee as set forth in the final
guidance document are new, CVM
estimates that the number of
respondents who would submit requests
would not increase. The number of
hours per respondent (30) encompasses
a wide range depending on the dispute
involved. The estimate was based on
discussions with industry and is an
average of hours per respondent.
AGENCY:
Annual Frequency
per Response
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: Circulatory
System Devices Panel of the Medical
Devices 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 April 22, 2005, from 8 a.m. to
4:30 p.m.
Location: Holiday Inn, Walker/
Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Geretta Wood, Center
for Devices and Radiological Health
(HFZ–450), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–443–8320,
ext. 143, or FDA Advisory Committee
VerDate jul<14>2003
15:31 Mar 14, 2005
Jkt 205001
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512625. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will hear a
presentation by the Office of
Surveillance and Biometrics outlining
their responsibility for the review of
postmarket study design. The committee
will also hear an update on the status of
recent devices brought before the
committee. The committee will discuss
and make recommendations on a
premarket notification submission for a
coronary proximal anastomosis device.
Background information for the topics,
including the agenda and questions for
the committee, will be available to the
public 1 business day before the
meeting on the Internet at https://
www.fda.gov/cdrh/panelmtg.html.
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 by April 7, 2005. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before April 7, 2005, 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.
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 AnnMarie
Williams, Conference Management
Staff, at 240–276–0450, ext. 113, at least
7 days in advance of the meeting.
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 7, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–5039 Filed 3–14–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: (301)
496–7057; fax: (301) 402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Karyotypic Complexity as a
Determinant of Anti-Cancer Drug
Activity
Ilan R. Kirsch and Anna V. Roschke
(NCI).
U.S. Provisional Patent Application
filed 04 Feb 2005 (DHHS Reference
No. E–101–2005/0–US–01).
Licensing Contact: Michelle A. Booden;
301/451–7337;
boodenm@mail.nih.gov.
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 70, Number 49 (Tuesday, March 15, 2005)]
[Notices]
[Pages 12699-12700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5040]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0167]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Final Guidance for
Industry on Dispute Resolution Procedures for Science-Based Decisions
on Products Regulated by 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 April
14, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
rm. 4B-41, Rockville, MD 20857, 301-827-1472.
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.
Title: Dispute Resolution Procedures for Science-Based Decisions on
Products Regulated by the Center for Veterinary Medicine
Description: FDA is issuing a final guidance on the Center for
Veterinary Medicine (CVM) process for formally resolving disputes
relating to scientific controversies. The final guidance describes
procedures for formally appealing such disputes. The final guidance
provides information on how the agency intends to interpret and apply
provisions of the existing regulations regarding internal agency review
of decisions (Sec. 10.75 (21 CFR 10.75)). In a final rule issued in
the Federal Register of November 18, 1998 (63 FR 63978), FDA amended
Sec. 10.75 to reflect the provisions of FDAMA. This final guidance
document outlines the recommended procedures for persons who are
applicants for approval of animal drugs or other products regulated by
CVM who wish to submit a request for review of a scientific dispute.
The final guidance recommends a procedure whereby applicants first
seek review through the supervisory chain of command. If the issue is
not resolved at the supervisor's level, the interested person may
request in writing that the matter be reviewed at the next higher
supervisory level. This process may continue throughout the agency's
entire supervisory chain of command through CVM and up to the level of
the Commissioner of Food and Drugs (Commissioner). At each level of
review (Division, Office Director, Deputy Center Director, and Center
Director levels) CVM recommends that the applicant identify the
information in the administrative file upon which the request is based.
If the appeal contains new information not previously contained in the
administrative file, the matter will, in accordance with 21 CFR
10.75(d), be returned to the appropriate lower level in CVM for
reevaluation based on that new information. After the applicant has
appealed the decision through the supervisory chain of command, they
may request review through an ad hoc appeals committee or review by the
Veterinary Medicine Advisory Committee (VMAC) in writing to the CVM
Ombudsman. If the applicant seeks review by the Ad Hoc Committee, the
Chair should provide them the opportunity to submit written arguments
to the Committee. The applicant may submit a letter appealing the Ad
Hoc Committee's decision to the CVM Director and then to the
Commissioner. CVM recommends that persons filing a request for review
by VMAC provide the CVM Ombudsman with a concise summary of the
scientific issue in dispute, including a summary of the particular FDA
action or decision to which the requesting party objects, the results
of all efforts that have been made to resolve the dispute to date, and
a clear articulated summary of the arguments and relevant data and
information.
The information collected will form the basis for resolving the
dispute between the requester and FDA. The likely respondents to this
collection of information are applicants for approval of animal drugs
or other products regulated by CVM who have a scientific dispute with
FDA and who request a review of the matter.
Based on FDA's experience with dispute resolution, the agency
expects that most persons seeking formal dispute resolution will have
gathered the materials during any previous efforts to resolve the
dispute with the agency. CVM considered the number and substance of
similar appeals made to FDA in recent years under Guide 1240.3130 to
arrive at numbers reflected in table 1 of this document. Guidance
79 will supercede Guide 1240.3130 and CVM will eliminate the
guide from the P & P Manual.
In the Federal Register of May 19, 2003 (68 FR 27094), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 12700]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Respondent Total Hours
----------------------------------------------------------------------------------------------------------------
Guidance 1 2 2 30 60
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The use of VMAC for resolving scientific disputes represents a new
process for CVM. Although the procedures for requesting dispute
resolution by a scientific advisory committee as set forth in the final
guidance document are new, CVM estimates that the number of respondents
who would submit requests would not increase. The number of hours per
respondent (30) encompasses a wide range depending on the dispute
involved. The estimate was based on discussions with industry and is an
average of hours per respondent.
Dated: March 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-5040 Filed 3-14-05; 8:45 am]
BILLING CODE 4160-01-S
