Proposed Collection; Comment Request; the NIH-American Association for Retired Persons (AARP) Interactive Comprehensive Lifestyle Interview by Computer Study (iCLIC) (NCI), 63833-63834 [2010-26187]
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Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices
maintained in the Quality System is
burdensome and provides no value to
ensuring protection of public health.
FDA agrees with these comments and
has revised the guidance to recommend
that only the parts of the Plan that could
have an effect on product quality be
reviewed and approved by the Quality
Unit before implementation of the Plan.
One comment stated that with
adequate inventory on hand, an
absenteeism-specific business plan
might not be needed. FDA disagrees
with the comment. As we discussed in
the guidance, potential shortages could
arise from emergencies not
contemplated by inventory policy.
One comment stated that establishing
provisions to use resources available at
other sites will require significant effort.
FDA recommends that these provisions
be considered as part of the overall Plan
for handling emergencies.
Some comments suggested different
timeframes for notifying FDA of
activation and deactivation of the Plan,
stating that 1 day is too short a time.
FDA did not change its recommendation
for 1-day notification for Plan activation
and deactivation because informing
FDA of this activity in as close to real
time as possible will assist the FDA in
making critical decisions related to
managing the causal event.
Some comments stated that testing the
implementation of the Plan and
producing test batches would be
impractical and expensive. FDA agrees
with these comments and has revised its
recommendation to test the
implementation of the Plan and
removed its recommendation to produce
test batches of the drug product.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency
per response
Number of
respondents
Total annual
responses
Hours per
response
Total hours
Notify FDA of Plan activation and deactivation ...................
2
1
2
16
32
Total ..............................................................................
........................
........................
........................
........................
32
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
Number of
recordkeepers
Annual
frequency per
recordkeeping
Develop initial Plan ..............................................................
70
1
70
500
35,000
Total ..............................................................................
........................
........................
........................
........................
35,000
1 There
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; the NIH–American
Association for Retired Persons
(AARP) Interactive Comprehensive
Lifestyle Interview by Computer Study
(iCLIC) (NCI)
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 Cancer Institute (NCI), 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.
SUMMARY:
VerDate Mar<15>2010
16:45 Oct 15, 2010
Jkt 223001
Title: NIHAmerican Association for Retired
Persons (AARP) interactive
Comprehensive Lifestyle Interview by
Computer Study (iCLIC). Type of
Information Collection Request:
Extension. Need and Use of Information
Collection: The Nutritional
Epidemiology Branch of the Division of
Cancer Epidemiology and Genetics of
the National Cancer Institute has
planned this study to evaluate the
feasibility of using these three new
computerized questionnaires as well as
the Diet and Health Questionnaire
(DHQ), a well-established food
frequency questionnaire in a population
of early-to-late-middle-aged men and
women. Participants will be asked to
complete computerized questionnaires
over a 90 day period, with some
questionnaires in a series being
completed twice. This evaluation study
comprises the necessary performance
and feasibility tests for the new
computerized questionnaires, which
will provide an opportunity to assess
the possibility of administering
computerized questionnaires in future
large prospective cohort studies. The
PROPOSED COLLECTION:
[FR Doc. 2010–26103 Filed 10–15–10; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES
Total annual
records
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
computerized questionnaires will
support the ongoing examination
between cancer and other health
outcomes with nutritional, physical
activity, and lifestyle exposures. The
computerized questionnaires adhere to
The Public Health Service Act, Section
412 (42 U.S.C. 285a–1) and Section 413
(42 U.S.C. 285a–2), which authorizes
the Division of Cancer Epidemiology
and Genetics of the National Cancer
Institute (NCI) to establish and support
programs for the detection, diagnosis,
prevention and treatment of cancer; and
to collect, identify, analyze and
disseminate information on cancer
research, diagnosis, prevention and
treatment. Frequency of Response:
Either 1 or 2 times. Affected Public:
Individuals. Type of Respondents: U.S.
adults (aged 50 and over). The annual
reporting burden is displayed in the
table below. The estimated total
annualized burden hours being
requested is 6886. The annualized cost
to respondents is estimated at $121,743.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
E:\FR\FM\18OCN1.SGM
18OCN1
63834
Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Frequency of
response
Instrument(s) tested
Read Invitation (Attachments 3) ..............................................
Pre-Enrollment (Attachment 6) ................................................
Enrollment Process (Attachment 7) .........................................
ASA24 (Attachments 4–1) .......................................................
ACT–24 (Attachments 4–2) .....................................................
LHQ (Attachments 4–3) ...........................................................
DHQ (Attachments 4–4) ..........................................................
Web Re-entry (Attachment 8) ..................................................
Evaluation Survey (Attachment 9) ...........................................
1.00
1.00
1.00
2.00
2.00
1.00
1.00
6.00
1.00
Totals ................................................................................
..............................
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) Evaluate 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) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Arthur Schatzkin,
M.D., Dr.P.H, Chief, Nutritional
Epidemiology Branch, Division of
Cancer Epidemiology and Genetics,
National Cancer Institute, NIH, DHHS,
Executive Plaza South, Room 3040,
6120 Executive Blvd., EPS–MSC 7242,
Bethesda, MD 20892–7335 or call nontoll-free number 301–594–2931 or email your request, including your
address to: schatzka@mail.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.
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSKH9S0YB1PROD with NOTICES
Average time per
response
(minutes/hour)
Dated: October 12, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–26187 Filed 10–15–10; 8:45 am]
BILLING CODE 4140–01–P
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16:45 Oct 15, 2010
Jkt 223001
1/60
10/60
5/60
30/60
15/60
20/60
45/60
5/60
1/60
Number of
respondents
Annual hour
burden
(0.017)
(0.167)
(0.083)
(0.500)
(0.250)
(0.333)
(0.750)
(0.083)
(0.017)
16,667.00
2,312.00
2,288.00
1,944.00
1,944.00
1,944.00
1,944.00
1,944.00
2,288.00
278
385
191
1,944
972
648
1,458
972
38
..............................
33,275.00
6,886
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Medical Devices: Current Good
Manufacturing Practice Quality System
Regulations—21
[Docket No. FDA–2010–N–0273]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Quality System
Regulations
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
17, 2010.
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 0910–0073. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
PO 00000
Frm 00037
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CFR Part 820 (OMB Control Number
0910–0073)—Extension
Under section 520(f) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C act) (21 U.S.C. 360j(f)), the
Secretary of the Department of Health
and Human Services has the authority
to prescribe regulations requiring that
the methods used in, and the facilities
and controls used for, the manufacture,
preproduction design validation
(including a process to assess the
performance of a device but not
including an evaluation of the safety
and effectiveness of a device), packing,
storage, and installation of a device
conform to current good manufacturing
practice (CGMP), as described in such
regulations, to assure that the device
will be safe and effective and otherwise
in compliance with the act.
The CGMP/quality system (QS)
regulation implementing authority
provided by this statutory provision is
found under part 820 (21 CFR part 820)
and sets forth basic CGMP requirements
governing the design, manufacture,
packing, labeling, storage, installation,
and servicing of all finished medical
devices intended for human use. The
authority for this regulation is covered
under sections 501, 502, 510, 513, 514,
515, 518, 519, 520, 522, 701, 704, 801,
and 803 of the FD&C act (21 U.S.C. 351,
352, 360, 360c, 360d, 360e, 360h, 360i,
360j, 360l, 371, 374, 381, and 383). The
CGMP/QS regulation includes
requirements for purchasing and service
controls, clarifies recordkeeping
requirements for device failure and
complaint investigations, clarifies
requirements for verifying/validating
production processes and process or
product changes, and clarifies
E:\FR\FM\18OCN1.SGM
18OCN1
]]>Agencies
[Federal Register Volume 75, Number 200 (Monday, October 18, 2010)]
[Notices]
[Pages 63833-63834]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26187]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; the NIH-American
Association for Retired Persons (AARP) Interactive Comprehensive
Lifestyle Interview by Computer Study (iCLIC) (NCI)
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 Cancer Institute
(NCI), 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: NIH-American Association for Retired
Persons (AARP) interactive Comprehensive Lifestyle Interview by
Computer Study (iCLIC). Type of Information Collection Request:
Extension. Need and Use of Information Collection: The Nutritional
Epidemiology Branch of the Division of Cancer Epidemiology and Genetics
of the National Cancer Institute has planned this study to evaluate the
feasibility of using these three new computerized questionnaires as
well as the Diet and Health Questionnaire (DHQ), a well-established
food frequency questionnaire in a population of early-to-late-middle-
aged men and women. Participants will be asked to complete computerized
questionnaires over a 90 day period, with some questionnaires in a
series being completed twice. This evaluation study comprises the
necessary performance and feasibility tests for the new computerized
questionnaires, which will provide an opportunity to assess the
possibility of administering computerized questionnaires in future
large prospective cohort studies. The computerized questionnaires will
support the ongoing examination between cancer and other health
outcomes with nutritional, physical activity, and lifestyle exposures.
The computerized questionnaires adhere to The Public Health Service
Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2),
which authorizes the Division of Cancer Epidemiology and Genetics of
the National Cancer Institute (NCI) to establish and support programs
for the detection, diagnosis, prevention and treatment of cancer; and
to collect, identify, analyze and disseminate information on cancer
research, diagnosis, prevention and treatment. Frequency of Response:
Either 1 or 2 times. Affected Public: Individuals. Type of Respondents:
U.S. adults (aged 50 and over). The annual reporting burden is
displayed in the table below. The estimated total annualized burden
hours being requested is 6886. The annualized cost to respondents is
estimated at $121,743. There are no Capital Costs, Operating Costs,
and/or Maintenance Costs to report.
[[Page 63834]]
Table 1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time per
Instrument(s) tested Frequency of response Number of Annual hour
response (minutes/hour) respondents burden
----------------------------------------------------------------------------------------------------------------
Read Invitation (Attachments 3)..... 1.00 1/60 (0.017) 16,667.00 278
Pre-Enrollment (Attachment 6)....... 1.00 10/60 (0.167) 2,312.00 385
Enrollment Process (Attachment 7)... 1.00 5/60 (0.083) 2,288.00 191
ASA24 (Attachments 4-1)............. 2.00 30/60 (0.500) 1,944.00 1,944
ACT-24 (Attachments 4-2)............ 2.00 15/60 (0.250) 1,944.00 972
LHQ (Attachments 4-3)............... 1.00 20/60 (0.333) 1,944.00 648
DHQ (Attachments 4-4)............... 1.00 45/60 (0.750) 1,944.00 1,458
Web Re-entry (Attachment 8)......... 6.00 5/60 (0.083) 1,944.00 972
Evaluation Survey (Attachment 9).... 1.00 1/60 (0.017) 2,288.00 38
�������������������������������������
Totals.......................... ................. ................. 33,275.00 6,886
----------------------------------------------------------------------------------------------------------------
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) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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 Arthur Schatzkin, M.D., Dr.P.H, Chief, Nutritional
Epidemiology Branch, Division of Cancer Epidemiology and Genetics,
National Cancer Institute, NIH, DHHS, Executive Plaza South, Room 3040,
6120 Executive Blvd., EPS-MSC 7242, Bethesda, MD 20892-7335 or call
non-toll-free number 301-594-2931 or e-mail your request, including
your address to: schatzka@mail.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: October 12, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-26187 Filed 10-15-10; 8:45 am]
BILLING CODE 4140-01-P
