Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Public Advisory Panels or Committees and Request for Nonvoting Industry Representatives on Public Advisory Panels or Committees, 40311-40313 [E7-14206]
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40311
Federal Register / Vol. 72, No. 141 / Tuesday, July 24, 2007 / Notices
devices sold in the United States. The
required information is unique to the
batch of color additive that is the subject
of a request for certification. The
manufacturer’s batch number is used for
temporarily identifying a batch of color
additive until FDA issues a certification
lot number and for identifying a
certified batch during inspections. The
manufacturer’s batch number also aids
in tracing the disposal of a certified
batch or a batch that has been refused
certification for noncompliance with the
color additive regulations. The
manufacturer’s batch weight is used for
assessing the certification fee. The batch
weight also is used to account for the
disposal of a batch of certified or
certification-rejected color additive. The
batch weight can be used in a recall to
determine whether all unused color
additive in the batch has been recalled.
The manufacturer’s name and address
and the name and address of the person
requesting certification are used to
contact the person responsible should a
question arise concerning compliance
with the color additive regulations.
Information on storage conditions
pending certification is used to evaluate
whether a batch of certified color
additive is inadvertently or
intentionally altered in a manner that
would make the sample submitted for
certification analysis unrepresentative
of the batch. FDA checks storage
information during inspections.
Information on intended uses for a batch
of color additive is used to assure that
a batch of certified color additive will be
used in accordance with the
requirements of its listing regulation.
The statement of the fee on a
certification request is used for
accounting purposes so that a person
requesting certification can be notified
promptly of any discrepancies.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
80.21
32
174
5,568
0.20
1,114
80.22
32
174
5,568
0.05
278
0.25
1,392
TOTAL
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
80.39
Annual Frequency
of Recordkeeping
32
Total Annual
Records
174
Hours per
Record
5,568
Total Hours
0.25
TOTAL
mstockstill on PROD1PC66 with NOTICES
1 There
1,392
1,392
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on its review
of the certification requests received
over the past 3 fiscal years (FY). The
annual burden estimate for this
information collection is 2,784 hours.
The estimated reporting burden for this
information collection is 1,392 hours
and the estimated recordkeeping burden
for this information collection is 1,392
hours. From FY 2004 to FY 2006, FDA
processed an average of 5,568 responses
(requests for certification of batches of
color additives) per year. There were 32
different respondents, corresponding to
an average of approximately 174
responses from each respondent per
year. Using information from industry
personnel, FDA estimates that an
average of 0.25 hour per response is
required for reporting (preparing
certification requests and accompanying
sample labels) and an average of 0.25
hour per response is required for
recordkeeping.
On February 13, 2006, FDA
introduced a Web-based Color
Certification information system. The
system was fully operational for FY
2007. This system allows certifiers to
VerDate Aug<31>2005
17:50 Jul 23, 2007
Jkt 211001
request color certification on-line,
follow their submissions through the
process, and obtain information on
account status. The system sends back
the certification results electronically,
allowing certifiers to sell their certified
color before receiving hard copy
certificates. Any delays in the system
result only from shipment of color
additive samples to FDA’s Office of
Cosmetics and Colors for analysis. FDA
expects future reductions in the hour
burdens for reporting and recordkeeping
from use of the Web-based system.
Dated: July 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–14201 Filed 7–23–07; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Notification From Industry
Organizations Interested in
Participating in Selection Process for
Nonvoting Industry Representatives on
Public Advisory Panels or Committees
and Request for Nonvoting Industry
Representatives on Public Advisory
Panels or Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on the National Mammography
Quality Assurance Advisory Committee
(NMQAAC) and certain device panels of
the Medical Devices Advisory
Committee in the Center for Devices and
Radiological Health notify FDA in
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24JYN1
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Federal Register / Vol. 72, No. 141 / Tuesday, July 24, 2007 / Notices
writing. A nominee may either be selfnominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
Any industry organizations
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
the FDA by August 23, 2007, for the
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by August 23, 2007.
DATES:
All letters of interest and
nominations should be sent to Kathleen
L. Walker (see FOR FURTHER INFORMATION
CONTACT).
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ–17), Food
and Drug Administration, 7520 Standish
Pl. (MPN1), Rockville, MD 20855, 240–
276–8938, e-mail:
kathleen.walker@fda.hhs.gov.
The
agency intends to add nonvoting
industry representatives to its advisory
committee identified below:
SUPPLEMENTARY INFORMATION:
I. CDRH—Various Committees and
Panels
A. National Mammography Quality
Assurance Advisory Committee
(NMQAAC)
The Mammography Quality Standards
Reauthorization Act of 2004 (Public Law
108–365) requires the addition of at
least two industry representatives with
expertise in mammography equipment
to the NMQAAC.
B. Medical Devices Advisory Committee
Section 520(f)(3) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360j(f)(3)), as amended by the
Medical Device Amendments of 1976,
provides that each medical device panel
include one nonvoting member to
represent the interests of the medical
device manufacturing industry.
II. CDRH—Committee and Panel
Functions
FDA is requesting nominations for
nonvoting members representing
industry interests for the following
vacancies listed in table 1 of this
document.
TABLE 1.
Committee Name or Panel
Approximate Date Needed
NMQAAC–The functions of the NMQAAC are to advise FDA on the following topics: (1) Developing appropriate quality standards and regulations for mammography facilities, (2) developing appropriate standards and regulations for bodies
accrediting mammography facilities under this program, (3) developing regulations with respect to sanctions, (4) developing procedures for monitoring compliance with standards, (5) establishing a mechanism to investigate consumer
complaints, (6) reporting new developments concerning breast imaging that
should be considered in the oversight of mammography facilities, (7) determining whether there exists a shortage of mammography facilities in rural and
health professional shortage areas and determining the effects of personnel on
access to the services of such facilities in such areas, (8) determining whether
there will exist a sufficient number of medical physicists after October 1, 1999,
and (9) determining the costs and benefits of compliance with these requirements
mstockstill on PROD1PC66 with NOTICES
Certain Panel of the Medical Devices Advisory Committee–The medical device
panels perform the following functions: (1) Review and evaluate data on the
safety and effectiveness of marketed and investigational devices and make recommendations for their regulation, (2) advise the Commissioner of Food and
Drugs (the Commissioner) regarding recommended classification or reclassification of these devices into one of three regulatory categories, (3) advise on any
possible risks to health associated with the use of devices, (4) advise on formulation of product development protocols, (5) review premarket approval applications for medical devices, (6) review guidelines and guidance documents, (7)
recommend exemption to certain devices from the application of portions of the
act, (8) advise on the necessity to ban a device, (9) respond to requests from
the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices, and (10) make recommendations on the quality in the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices.
Clinical Chemistry and Clinical Toxicology Devices Panel
Gastroenterology and Urology Devices Panel
Medical Devices Dispute Resolution Panel
Microbiology Devices Panel
Molecular and Clinical Genetics Devices Panel
Orthopaedic and Rehabilitation Devices Panel
Radiological Devices Panel
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the
contact person (see FOR FURTHER
VerDate Aug<31>2005
17:50 Jul 23, 2007
Jkt 211001
February 1, 2008
March 1, 2008
January 1, 2008
October 1, 2008
March 1, 2008
June 1, 2008
September 1, 2008
February 1, 2008
INFORMATION CONTACT) within 30 days of
publication of this notice. Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations,
and a list of all nominees along with
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their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
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Federal Register / Vol. 72, No. 141 / Tuesday, July 24, 2007 / Notices
interests for a particular committee or
device panel. The interested
organizations are not bound by the list
of nominees in selecting a candidate.
However, if no individual is selected
within the 60 days, the Commissioner of
Food and Drugs will select the
nonvoting member to represent industry
interests.
IV. Qualifications
Persons nominated for membership as
an industry representative on the
NMQAAC must meet the following
criteria: (1) Demonstrate expertise in
mammography equipment, and (2) be
able to discuss equipment specifications
and quality control procedures affecting
mammography equipment. The industry
representative must be able to represent
the industry perspective on issues and
actions before the advisory committee,
serve as liaison between the committee
and interested industry parties, and
facilitate dialogue with the advisory
committee on mammography equipment
issues.
B. Medical Devices Advisory Committee
Persons nominated for the device
panels should be full-time employees of
firms that manufacture products that
would come before the panel, or
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
V. Application Procedure
mstockstill on PROD1PC66 with NOTICES
Dated: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–14206 Filed 7–23–07; 8:45 am]
BILLING CODE 4160–01–S
A. NMQAAC
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. A current
curriculum vitae and the name of the
committee of interest should be sent to
the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within
the 30 days. FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages, nominations
for appropriately qualified candidates
from these groups. Specifically, in this
document, nominations for nonvoting
representatives of industry interests are
encouraged from the food production
and manufacturing industry; the dietary
supplement manufacturing industry;
VerDate Aug<31>2005
and the agricultural biotechnology
manufacturing industry.
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.
17:50 Jul 23, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection: Comment
Request; Revision of OMB; No. 0925–
0001/exp. 09/30/07, ‘‘Research and
Research Training Grant Applications
and Related Forms’’
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
Office of Extramural Research, 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.
Proposed Collection: Title: Research
and Research Training Grant
Applications and Related Forms. Type
of Information Collection Request:
Revision, OMB 0925–0001, Expiration
Date 9/30/07. Form Numbers: PHS 398,
2590, 2271, 3734 and HHS 568. Need
and Use of Information Collection: The
application is used by applicants to
request Federal assistance for research
and research-related training. The other
related forms are used for trainee
appointment, final invention reporting,
and to relinquish rights to a research
grant. Frequency of response:
Applicants may submit applications for
published receipt dates. If awarded,
annual progress is reported and trainees
may be appointed or reappointed.
Affected Public: Individuals or
Households; Business or other for-profit;
Not-for-profit institutions; Federal
Government; and State, Local or Tribal
Government. Type of Respondents:
Adult scientific professionals. The
annual reporting burden is as follows:
Estimated Number of Respondents:
158,820; Estimated Number of
Responses per Respondent: 1; Average
Burden Hours Per Response: 15.8; and
Estimated Total Annual Burden Hours
Requested: 2,517,466. The estimated
annualized cost to respondents is
$88,058,547.
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40313
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) 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) 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) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to 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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Ms. Mikia Currie,
Division of Grants Policy, Office of
Policy for Extramural Research
Administration, NIH, Rockledge 1
Building, Room 3505, 6705 Rockledge
Drive, Bethesda, MD 20892–7974, or
call non-toll-free number 301–435–
0941, or e-mail your request, including
your address to: curriem@od.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
Dated: July 16, 2007.
Mikia Currie,
OPERA, Office of Extramural Research,
National Institutes of Health.
[FR Doc. E7–14214 Filed 7–23–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
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
E:\FR\FM\24JYN1.SGM
24JYN1
]]>Agencies
[Federal Register Volume 72, Number 141 (Tuesday, July 24, 2007)]
[Notices]
[Pages 40311-40313]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Notification From Industry Organizations Interested
in Participating in Selection Process for Nonvoting Industry
Representatives on Public Advisory Panels or Committees and Request for
Nonvoting Industry Representatives on Public Advisory Panels or
Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on the National Mammography
Quality Assurance Advisory Committee (NMQAAC) and certain device panels
of the Medical Devices Advisory Committee in the Center for Devices and
Radiological Health notify FDA in
[[Page 40312]]
writing. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
Nominations will be accepted for current vacancies effective with this
notice.
DATES: Any industry organizations interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to the FDA by August
23, 2007, for the vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
by August 23, 2007.
ADDRESSES: All letters of interest and nominations should be sent to
Kathleen L. Walker (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 7520
Standish Pl. (MPN1), Rockville, MD 20855, 240-276-8938, e-mail:
kathleen.walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The agency intends to add nonvoting industry
representatives to its advisory committee identified below:
I. CDRH--Various Committees and Panels
A. National Mammography Quality Assurance Advisory Committee (NMQAAC)
The Mammography Quality Standards Reauthorization Act of 2004
(Public Law 108-365) requires the addition of at least two industry
representatives with expertise in mammography equipment to the NMQAAC.
B. Medical Devices Advisory Committee
Section 520(f)(3) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360j(f)(3)), as amended by the Medical Device
Amendments of 1976, provides that each medical device panel include one
nonvoting member to represent the interests of the medical device
manufacturing industry.
II. CDRH--Committee and Panel Functions
FDA is requesting nominations for nonvoting members representing
industry interests for the following vacancies listed in table 1 of
this document.
Table 1.
------------------------------------------------------------------------
Committee Name or Panel Approximate Date Needed
------------------------------------------------------------------------
NMQAAC-The functions of the NMQAAC are February 1, 2008
to advise FDA on the following topics:
(1) Developing appropriate quality
standards and regulations for
mammography facilities, (2) developing
appropriate standards and regulations
for bodies accrediting mammography
facilities under this program, (3)
developing regulations with respect to
sanctions, (4) developing procedures
for monitoring compliance with
standards, (5) establishing a mechanism
to investigate consumer complaints, (6)
reporting new developments concerning
breast imaging that should be
considered in the oversight of
mammography facilities, (7) determining
whether there exists a shortage of
mammography facilities in rural and
health professional shortage areas and
determining the effects of personnel on
access to the services of such
facilities in such areas, (8)
determining whether there will exist a
sufficient number of medical physicists
after October 1, 1999, and (9)
determining the costs and benefits of
compliance with these requirements
------------------------------------------------------------------------
Certain Panel of the Medical Devices ..............................
Advisory Committee-The medical device
panels perform the following functions:
(1) Review and evaluate data on the
safety and effectiveness of marketed
and investigational devices and make
recommendations for their regulation,
(2) advise the Commissioner of Food and
Drugs (the Commissioner) regarding
recommended classification or
reclassification of these devices into
one of three regulatory categories, (3)
advise on any possible risks to health
associated with the use of devices, (4)
advise on formulation of product
development protocols, (5) review
premarket approval applications for
medical devices, (6) review guidelines
and guidance documents, (7) recommend
exemption to certain devices from the
application of portions of the act, (8)
advise on the necessity to ban a
device, (9) respond to requests from
the agency to review and make
recommendations on specific issues or
problems concerning the safety and
effectiveness of devices, and (10) make
recommendations on the quality in the
design of clinical studies regarding
the safety and effectiveness of
marketed and investigational devices.
Clinical Chemistry and Clinical March 1, 2008
Toxicology Devices Panel
Gastroenterology and Urology Devices January 1, 2008
Panel
Medical Devices Dispute Resolution October 1, 2008
Panel
Microbiology Devices Panel March 1, 2008
Molecular and Clinical Genetics June 1, 2008
Devices Panel
Orthopaedic and Rehabilitation September 1, 2008
Devices Panel
Radiological Devices Panel February 1, 2008
------------------------------------------------------------------------
III. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this notice. Within the subsequent 30 days, FDA will
send a letter to each organization that has expressed an interest,
attaching a complete list of all such organizations, and a list of all
nominees along with their current resumes. The letter will also state
that it is the responsibility of the interested organizations to confer
with one another and to select a candidate, within 60 days after the
receipt of the FDA letter, to serve as the nonvoting member to
represent industry
[[Page 40313]]
interests for a particular committee or device panel. The interested
organizations are not bound by the list of nominees in selecting a
candidate. However, if no individual is selected within the 60 days,
the Commissioner of Food and Drugs will select the nonvoting member to
represent industry interests.
IV. Qualifications
A. NMQAAC
Persons nominated for membership as an industry representative on
the NMQAAC must meet the following criteria: (1) Demonstrate expertise
in mammography equipment, and (2) be able to discuss equipment
specifications and quality control procedures affecting mammography
equipment. The industry representative must be able to represent the
industry perspective on issues and actions before the advisory
committee, serve as liaison between the committee and interested
industry parties, and facilitate dialogue with the advisory committee
on mammography equipment issues.
B. Medical Devices Advisory Committee
Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers, or have
similar appropriate ties to industry.
V. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. A current curriculum vitae and the name of the
committee of interest should be sent to the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within the 30 days. FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the committee. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees, and therefore,
encourages, nominations for appropriately qualified candidates from
these groups. Specifically, in this document, nominations for nonvoting
representatives of industry interests are encouraged from the food
production and manufacturing industry; the dietary supplement
manufacturing industry; and the agricultural biotechnology
manufacturing industry.
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: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-14206 Filed 7-23-07; 8:45 am]
BILLING CODE 4160-01-S
