Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices, 61455-61457 [05-21158]
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61455
Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
whether advisory committee review is
sought, and the expected outcome; (2) a
statement identifying the review
division/office that issued the original
decision on the matter and, if
applicable, the last agency official that
attempted to formally resolve the
matter; (3) a list of documents in the
administrative file, or additional copies
of such documents, that are deemed
necessary for resolution of the issue(s);
and (4) a statement that the previous
supervisory level has already had the
opportunity to review all of the material
relied on for dispute resolution. The
agency suggests submitting the
following information with a formal
request for dispute resolution: (1)
Statements describing the issue from the
perspective of the person with a
dispute, (2) brief statements describing
the history of the matter, and (3) the
documents previously submitted to FDA
under an OMB approved collection of
information.
Based on FDA’s experience with
dispute resolution, the agency expects
that most persons seeking formal
dispute resolution will have gathered
the materials listed previously when
identifying the existence of a dispute
with the agency. Consequently, FDA
anticipates that the collection of
information attributed solely to the
guidance will be minimal.
Respondents are expected to be
sponsors, applicants, or manufacturers
of drug or biological products regulated
by the agency under section 505 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the
Public Health Service Act (42 U.S.C.
262) who request formal resolution of a
scientific or procedural dispute.
Provided below is an estimate of the
annual reporting burden for requests for
dispute resolution. Based on data
collected from review divisions and
offices within CDER and CBER, FDA
estimates that approximately eight
sponsors and applicants (respondents)
submit requests for formal dispute
resolution to CDER annually and
approximately one respondent submits
requests for formal dispute resolution to
CBER annually. The total annual
responses are the total number of
requests submitted to CDER and CBER
in 1 year, including requests for dispute
resolution that a single respondent
submits more than one time. FDA
estimates that CDER receives
approximately 10 requests annually and
CBER receives approximately 1 request
annually. The hours per response are
the estimated number of hours that a
respondent would spend preparing the
information to be submitted with a
request for formal dispute resolution in
accordance with this guidance,
including the time it takes to gather and
copy brief statements describing the
issue from the perspective of the person
with the dispute, brief statements
describing the history of the matter, and
supporting information that has already
been submitted to the agency. Based on
experience, FDA estimates that
approximately 8 hours on average
would be needed per response.
Therefore, FDA estimates that 88 hours
will be spent per year by respondents
requesting formal dispute resolution
under the guidance.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Requests for Formal Dispute
Resolution
No. of
Respondents
Number of Responses
per Respondent
CDER
8
1.25
CBER
1
Total Annual
Responses
1
Hours per
Response
Total Hours
10
8
80
1
8
8
Total
88
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21156 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2004N–0516]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
2005 Food Safety Survey
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘2005 Food Safety Survey’’ has been
approved by the Office of Management
SUMMARY:
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15:19 Oct 21, 2005
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FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In the
Federal Register of May 24, 2005 (70 FR
29768), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0345. The
approval expires on February 30, 2008.
A copy of the supporting statement
for this information collection is
available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
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Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21157 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0216]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices:
Humanitarian Use Devices
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
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Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by November
23, 2005.
DATES:
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 comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Medical Devices: Humanitarian Use
Devices—21 CFR Part 814 (OMB
Control Number 0910–0332)—Extension
This collection implements the
humanitarian use device (HUD)
Provision under section 520(m) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360j(m)) and 21 CFR
part 814, subpart H. Under section
520(m) of the act, FDA is authorized to
exempt an HUD from the effectiveness
requirements of sections 514 and 515 of
the act (21 U.S.C. 360d and 360e)
provided that the device do the
following: (1) Is used to treat or
diagnosis a disease or condition that
affects fewer than 4,000 individuals in
the United States; (2) would not be
available to a person with such a disease
or condition unless the exemption is
granted, and there is no comparable
device, other than another HUD
approved under this exemption,
available to treat or diagnose the disease
or condition; and (3) the device will not
expose patients to an unreasonable or
significant risk of illness or injury, and
the probable benefit to health from
using the device outweighs the risk of
injury or illness from its use, taking into
account the probable risks and benefits
of currently available devices or
alternative forms of treatment.
The information collection will allow
FDA to determine whether to do the
following: (1) Grant HUD designation of
a medical device, (2) exempt a HUD
from the effectiveness requirements in
sections 514 and 515 of the act provided
that the device meets requirements set
forth in section 520(m) of the act, and
(3) grants marketing approval(s) for the
HUD. Failure to collect this information
would prevent FDA from making those
determinations. Also, this information
enables FDA to determine whether the
holder of a HUD is in compliance with
the HUD requirements.
Description of Respondents:
Businesses or others for-profit.
In the Federal Register of June 16,
2005 (70 FR 35098), 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Annual Frequency per
Respondent
No. of Respondents
Total Annual Responses
Hours per Response
Total Hours
814.102
20
1
20
40
800
814.104
8
1
8
320
2,560
814.106
8
2
16
50
800
814.108
20
1
20
80
1,600
814.116(e)(3)
1
1
1
1
1
814.124(a)
5
1
5
1
5
814.124(b)
1
1
1
2
2
35
1
35
120
4,200
814.126(b)(1)
Total
9,968
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
35
21 CFR Section
1
35
814.126(b)(2)
1There
Hours per Recordkeeper
2
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21158 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
MicroArray Quality Control Project
Meeting on MicroArray Quality Control;
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘MicroArray
Quality Control (MAQC) Project
Meeting on MicroArray Quality
Control.’’ The focus of the 2-day
meeting will be to review the datasets
generated by the MAQC study.
Date and Time: The meeting will be
held on Thursday, December 1, 2005,
from 8 a.m. to 5 p.m. and Friday,
December 2, 2005, from 8 a.m. to 2 p.m.
Location: The meeting will be held at
the Crowne Plaza Cabana Portofino
Room on December 1, 2005, and the St.
Tropez Room on December 2, 2005,
4290 El Camino Real, Palo Alto, CA
94306, 650–857–0787, FAX: 650–496–
1939, Web site: https://
www.cppaloalto.crowneplaza.com/.
(FDA has verified the Web site address,
but is not responsible for subsequent
changes to the Web site after this
document publishes in the Federal
Register.)
Contact: Leming Shi, National Center
for Toxicological Research, Food and
Drug Administration, 3900 NCTR Rd.,
Jefferson, AR 72079, 870–543–7387,
FAX: 870–543–7686, e-mail:
leming.shi@fda.hhs.gov.
Registration: There will be no
registration fee for attending the
meeting. However, interested parties
should send registration information
(including name, title, firm name,
address, telephone, and fax number),
and written material and requests to
make oral presentations, to the contact
person (see Contact) at least 15 days in
advance of the meeting. Participants are
responsible for their own costs of travel,
lodging, and meals.
FDA welcomes the attendance of the
public at this meeting and will make
every effort to accommodate persons
with physical disabilities or special
needs. If you require special
accommodations due to a disability,
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15:19 Oct 21, 2005
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please contact Jeannette Coleman at
870–543–7087, e-mail:
jeanette.coleman@fda.hhs.gov, at least 7
days in advance of the meeting.
SUPPLEMENTARY INFORMATION: FDA’s
critical path initiative (https://
www.fda.gov/oc/initiatives/criticalpath/
) identifies pharmacogenomics as a key
opportunity in advancing medical
product development and personalized
medicine. FDA issued the ‘‘Guidance for
Industry: Pharmacogenomic Data
Submissions’’ (https://www.fda.gov/cder/
guidance/6400fnl.pdf) to facilitate
scientific progress in the field of
pharmacogenomics and to facilitate the
use of pharmacogenomic data in drug
development and medical diagnostics.
A microarray is a tool for analyzing gene
expression that consists of a small
membrane or glass slide containing
samples of many genes arranged in a
regular pattern. Microarrays represent a
core technology in pharmacogenomics;
however, before this technology can
successfully and reliably be applied in
clinical practice and regulatory
decisionmaking, standards and quality
measures need to be developed.
The MAQC project involves six FDA
centers, major providers of microarray
platforms and ribonucleic acid (RNA)
samples, government agencies,
academic laboratories, and other
stakeholders. The MAQC project aims to
evaluate quality control metrics and
thresholds for objectively assessing the
performance achievable by various
microarray platforms, and evaluating
the advantages and disadvantages of
various data analysis methods. Two
RNA samples will be selected for three
species (i.e., human, rat, and mouse),
and differential gene expression levels
between the two samples will be
calibrated with microarrays and other
technologies (e.g., quantitative real timepolymerase chain reaction (qRT–PCR)).
The resulting microarray datasets will
be used for assessing the precision and
crossplatform/laboratory comparability
of microarrays, and the qRT–PCR
datasets will enable evaluation of the
nature and magnitude of any systematic
biases that may exist between
microarrays and qRT–PCR. The
availability of the calibrated RNA
samples and the resulting microarray
and qRT–PCR datasets, which will be
made readily accessible to the
microarray community, will allow
individual laboratories to identify and
correct procedural failures more easily.
The MAQC project will help improve
the microarray technology and foster its
proper applications in discovery,
development and review of FDAregulated products. For more
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61457
information about the MAQC project,
please visit https://www.fda.gov/nctr/
science/centers/toxicoinformatics/
maqc/.
At the public meeting, each
participating platform provider will give
a 15-minute presentation to summarize
the datasets generated by its test sites
and to describe its analysis results. Each
analysis site will also give a 15-minute
presentation on its analysis results.
Other interested parties may present
data, information, or views, orally or in
writing, on issues related to microarray
quality control and data analysis. Those
desiring to make formal oral
presentations should notify the contact
person (see Contact) before November 4,
2005, and submit a brief statement of
the general nature of the evidence or
arguments they wish to present with an
indication of the approximate time
requested to make the presentation.
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21152 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Injuries Among Youth With
Developmental Disabilities
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.
Proposed Collection
Title: Injuries Among Youth with
Developmental Disabilities. Type of
Information Collection Request: New.
Use of Information: The proposed study
seeks (1) to determine if children with
disabilities are at increased risk of
injury compared to typically developing
children, and (2) to identify which
injuries children with developmental
disabilities are at particular risk of
sustaining. Existing data on this topic
are scarce and equivocal. Results will
help inform prevention efforts. NICHD
proposes to collect information about
disabilities among children with
injuries through phone interviews with
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[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Notices]
[Pages 61455-61457]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21158]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0216]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices:
Humanitarian Use Devices
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
[[Page 61456]]
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 23, 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 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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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.
Medical Devices: Humanitarian Use Devices--21 CFR Part 814 (OMB Control
Number 0910-0332)--Extension
This collection implements the humanitarian use device (HUD)
Provision under section 520(m) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360j(m)) and 21 CFR part 814, subpart H. Under
section 520(m) of the act, FDA is authorized to exempt an HUD from the
effectiveness requirements of sections 514 and 515 of the act (21
U.S.C. 360d and 360e) provided that the device do the following: (1) Is
used to treat or diagnosis a disease or condition that affects fewer
than 4,000 individuals in the United States; (2) would not be available
to a person with such a disease or condition unless the exemption is
granted, and there is no comparable device, other than another HUD
approved under this exemption, available to treat or diagnose the
disease or condition; and (3) the device will not expose patients to an
unreasonable or significant risk of illness or injury, and the probable
benefit to health from using the device outweighs the risk of injury or
illness from its use, taking into account the probable risks and
benefits of currently available devices or alternative forms of
treatment.
The information collection will allow FDA to determine whether to
do the following: (1) Grant HUD designation of a medical device, (2)
exempt a HUD from the effectiveness requirements in sections 514 and
515 of the act provided that the device meets requirements set forth in
section 520(m) of the act, and (3) grants marketing approval(s) for the
HUD. Failure to collect this information would prevent FDA from making
those determinations. Also, this information enables FDA to determine
whether the holder of a HUD is in compliance with the HUD requirements.
Description of Respondents: Businesses or others for-profit.
In the Federal Register of June 16, 2005 (70 FR 35098), 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:
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual
21 CFR Section No. of Respondents Respondent Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.102 20 1 20 40 800
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.104 8 1 8 320 2,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.106 8 2 16 50 800
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.108 20 1 20 80 1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.116(e)(3) 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(a) 5 1 5 1 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.124(b) 1 1 1 2 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(1) 35 1 35 120 4,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ..................... .................... .................... ..................... 9,968
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Hours per
21 CFR Section Recordkeepers Recordkeeping Total Annual Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.126(b)(2) 35 1 35 2 70
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 61457]]
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21158 Filed 10-21-05; 8:45 am]
BILLING CODE 4160-01-S
