Submission for OMB Review; Comment Request; The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL), 52153-52155 [E7-17986]
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Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices
52153
TABLE 3.—Continued
Item No.
Title of Standard
Reference No. and Date
222
Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment
ANSI/AAMI/ISO 18472:2006
223
Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements
ANSI/AAMI/ISO 11138–1:2006
224
Sterilization of Health Care Products—Radiation—Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
ANSI/AAMI/ISO 11137–1:2006
225
Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization
Dose
ANSI/AAMI/ISO 11137–2:2006
226
Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric Aspects
ANSI/AAMI/ISO 11137–3:2006
H. Tissue Engineering
9
Standard Guide for Classification of Therapeutic Skin Substitutes
ASTM F2311–06
10
Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
ASTM F2451–05
IV. List of Recognized Standards
VI. Electronic Access
FDA maintains the agency’s current
list of FDA recognized consensus
standards in a searchable database that
may be accessed directly at FDA’s Web
site at https://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfstandards/
search.cfm. FDA will incorporate the
modifications and minor revisions
described in this notice into the
database and, upon publication in the
Federal Register, this recognition of
consensus standards will be effective.
FDA will announce additional
modifications and minor revisions to
the list of recognized consensus
standards, as needed, in the Federal
Register once a year, or more often, if
necessary.
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page includes the guidance
as well as the current list of recognized
standards and other standards related
documents. After publication in the
Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 018’’ will be available on the
CDRH home page. You may access the
CDRH home page at https://www.fda.gov/
cdrh.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for ‘‘FDA Recognized Consensus
Standards’’ through the hyperlink at
https://www.fda.gov/cdrh/stdsprog.html.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfTopic/cdrhnew.cfm.
jlentini on PROD1PC65 with NOTICES
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under the new provision of
section 514 of the act by submitting
such recommendations, with reasons for
the recommendation, to the contact
person (See FOR FURTHER INFORMATION
CONTACT). To be properly considered
such recommendations should contain,
at a minimum, the following
information: (1) Title of the standard, (2)
any reference number and date, (3)
name and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
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18:43 Sep 11, 2007
Jkt 211001
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) written or
electronic comments regarding this
document. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
PO 00000
Frm 00109
Fmt 4703
Sfmt 4703
with the docket number found in
brackets in the heading of this
document. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
018. These modifications to the list or
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: August 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–18021 Filed 9–11–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; The Hispanic
Community Health Study (HCHS)/
Study of Latinos (SOL)
SUMMARY: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on July 11, 2007, pages 37789–
37790, and allowed 60-days for public
comment. No comments were received.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
E:\FR\FM\12SEN1.SGM
12SEN1
52154
Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Proposed Collection: Title: Hispanic
Community Health Study (HCHS)/
Study of Latinos (SOL).
Type of Information Collection
Request: New Collection. Need and Use
of Information Collection: The Hispanic
Community Health Study (HCHS)/
Study of Latinos (SOL) will identify risk
factors for cardiovascular and lung
disease in Hispanic populations and
determine the role of acculturation in
the prevalence and development of
these diseases. Hispanics, now the
largest minority population in the US,
are influenced by factors associated
with immigration from different cultural
settings and environments, including
changes in diet, activity, community
support, working conditions, and health
care access. This project is a
multicenter, six-and-a-half year
epidemiologic study and will recruit
16,000 Hispanic men and women aged
18–74 in four community-based cohorts
in Chicago, Miami, San Diego, and the
Bronx. The study will also examine
measures of obesity, physical activity,
nutritional habits, diabetes, lung and
sleep function, cognitive function,
hearing, and dental conditions. Closely
integrated with the research component
will be a community and professional
education component, with the goals of
bringing the research results back to the
community, improving recognition and
control of risk factors, and attracting and
training Hispanic researchers in
epidemiology and population-based
research.
Frequency of Response: The
participants will be contacted annually.
Affected Public: Individuals or
households; Businesses or other for
profit; Small businesses or
organizations. Type of Respondents:
Individuals or households; physicians.
The annual reporting burden is as
follows: Estimated Number of
Respondents: 39,844; Estimated Number
of Responses per Respondent: 1.0;
Average Burden Hours Per Response:
1.1; and Estimated Total Annual Burden
Hours Requested: 44,688. The
annualized cost to respondents is
estimated at $149,415, assuming
respondents time at the rate of $15 per
hour and physician time at the rate of
$55 per hour. There are no Capital Costs
to report. There are no Operating or
Maintenance Costs to report.
TABLE A.12.1.—ESTIMATE OF RESPONDENT BURDEN HCHS/SOL
Number of
respondents
Type of response
Time per
response
(hours)
Number of
responses
Burden
(hours)
a. Recruitment contacts ...................................................................................
b. Household enumeration ..............................................................................
c. Telephone contact to set up appointment ...................................................
d. Appointment Confirmation ...........................................................................
e. CLINIC EXAM:
e1. Procedures .........................................................................................
e2. Questionnaires ...................................................................................
f. Participant Telephone Interviews:
24-hour Dietary Intake Recall ...................................................................
Follow-Up Call ..........................................................................................
22,369
4,191
6,667
6,667
1
1
1
1
0.08
0.17
0.08
0.08
1,790
712
533
533
5,333
5,333
1
1
3.67
2.75
19,572
14,666
5,333
5,333
1
1
0.67
0.50
3,573
2,667
Total, Participant ...............................................................................
38,560
........................
........................
44,046
Non-participant components: 1
a. Physician, hospital and nursing home contacts for outcomes ascertainment (total = 1,254):
Deaths ...............................................................................................
CHF ...................................................................................................
Stroke ................................................................................................
CHD ...................................................................................................
COPD ................................................................................................
Asthma ..............................................................................................
b. Informant contact ..................................................................................
60
90
132
650
210
112
30
1
........................
........................
........................
........................
........................
1
0.50
........................
........................
........................
........................
........................
0.50
627
........................
........................
........................
........................
........................
15
Total, Participant and Non-Participant Components .........................
39,844
........................
........................
44,688
1 Annual
jlentini on PROD1PC65 with NOTICES
burden is place on physicians and health care providers and respondent relatives/informants through request for information which
will help in the compilation of the number and nature of new fatal and non-fatal events.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address 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
VerDate Aug<31>2005
18:43 Sep 11, 2007
Jkt 211001
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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
PO 00000
Frm 00110
Fmt 4703
Sfmt 4703
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Larissa Aviles-Santa, Deputy Project
Officer, NIH, NHLBI, 6701 Rockledge
E:\FR\FM\12SEN1.SGM
12SEN1
52155
Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices
Drive, MSC 7936, Bethesda, MD 20892–
7936, or call non-toll-free number 301–
435–1284 or E-mail your request,
including your address to:
AvilessantaL@NHLBI.NIH.GOV.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: September 7, 2007.
Mike Lauer,
Director, Division of Prevention and
Population Sciences, NHLBI, National
Institutes of Health.
Dated: September 7, 2007.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of
Health.
[FR Doc. E7–17986 Filed 9–11–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; The Cardiovascular Health
Study (CHS)
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 Heart, Lung, and Blood
Institute (NHLBI), 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: The
Cardiovascular Health Study. Type of
Information Request: Reinstatement.
(OMB No. 0925–0334). Need and Use of
Information Collection: This study
quantifies associations between
conventional and hypothetical risk
factors and coronary heart disease
(CHD) and stroke in people age 65 years
and older. The primary objectives
include quantifying associations of risk
factors with subclinical disease;
characterizing the natural history of
CHD and stroke; and identifying factors
associated with clinical course. The
findings provide important information
on cardiovascular disease in an older
U.S. population and lead to early
treatment of risk factors associated with
disease and identification of factors that
may be important in disease prevention.
OBM clearance is being sought for data
collection activities at only one of the
four CHS field centers (the Pittsburgh
field center), which are expected to end
on May 31, 2008. Other data collection
efforts in the CHS cohort are supported
by various non-contract funding
sources. Frequency of response: twice a
year (participants) or once per
cardiovascular disease event (proxies
and physicians); Affected public:
Individuals. Types of Respondents:
Individuals recruited for CHS and their
selected proxies and physicians. The
annual reporting burden is as follows:
Estimated Number of Respondents: 556;
Estimated Number of Responses per
respondent: 1.2; and Estimated Total
Annual Burden Hours Requested: 289.
The annualized cost to respondents is
estimated at: $14,450.
There are no capital, operating, or
maintenance costs to report.
Estimated number
of respondents
Estimated number
of responses per
respondent*
Participants ............................................................................
Physicians ..............................................................................
Participant proxies .................................................................
346
70
121
1.2
1.2
1.2
0.5
0.1
0.5
208
8
73
Total ................................................................................
537
1.2
0.45
289
Type of respondents
Average burden
hours per
response
Estimated total annual burden hours
requested
jlentini on PROD1PC65 with NOTICES
*Total for 3 years.
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 will have practical utility;
(2) The accuracy of the agency’s
estimate of 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
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
data collection plans and instruments,
VerDate Aug<31>2005
18:43 Sep 11, 2007
Jkt 211001
contact Dr. Jean Olson, Epidemiology
Branch, Division of Prevention and
Population Sciences, NHLBI, NIH, II
Rockledge Centre, 6701 Rockledge
Drive, Suite 10018, MSC # 7936,
Bethesda, MD 20892–7936, or call 301–
435–0397 (non-toll-free number), or email your request, including your
address to: OlsonJ@nhlbi.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.
PO 00000
Dated: August 29, 2007.
Mike Lauer,
Director, Division of Prevention and
Population Sciences, NHLBI, National
Institutes of Health.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of
Health.
[FR Doc. E7–18012 Filed 9–11–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Frm 00111
Fmt 4703
Sfmt 4703
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12SEN1
]]>Agencies
[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Pages 52153-52155]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17986]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; The Hispanic
Community Health Study (HCHS)/Study of Latinos (SOL)
SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of Health (NIH) has submitted to the
Office of Management and Budget (OMB) a request for review and approval
of the information collection listed below. This proposed information
collection was previously published in the Federal Register on July 11,
2007, pages 37789-37790, and allowed 60-days for public comment. No
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may
[[Page 52154]]
not conduct or sponsor, and the respondent is not required to respond
to, an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Proposed Collection: Title: Hispanic Community Health Study (HCHS)/
Study of Latinos (SOL).
Type of Information Collection Request: New Collection. Need and
Use of Information Collection: The Hispanic Community Health Study
(HCHS)/ Study of Latinos (SOL) will identify risk factors for
cardiovascular and lung disease in Hispanic populations and determine
the role of acculturation in the prevalence and development of these
diseases. Hispanics, now the largest minority population in the US, are
influenced by factors associated with immigration from different
cultural settings and environments, including changes in diet,
activity, community support, working conditions, and health care
access. This project is a multicenter, six-and-a-half year
epidemiologic study and will recruit 16,000 Hispanic men and women aged
18-74 in four community-based cohorts in Chicago, Miami, San Diego, and
the Bronx. The study will also examine measures of obesity, physical
activity, nutritional habits, diabetes, lung and sleep function,
cognitive function, hearing, and dental conditions. Closely integrated
with the research component will be a community and professional
education component, with the goals of bringing the research results
back to the community, improving recognition and control of risk
factors, and attracting and training Hispanic researchers in
epidemiology and population-based research.
Frequency of Response: The participants will be contacted annually.
Affected Public: Individuals or households; Businesses or other for
profit; Small businesses or organizations. Type of Respondents:
Individuals or households; physicians. The annual reporting burden is
as follows: Estimated Number of Respondents: 39,844; Estimated Number
of Responses per Respondent: 1.0; Average Burden Hours Per Response:
1.1; and Estimated Total Annual Burden Hours Requested: 44,688. The
annualized cost to respondents is estimated at $149,415, assuming
respondents time at the rate of $15 per hour and physician time at the
rate of $55 per hour. There are no Capital Costs to report. There are
no Operating or Maintenance Costs to report.
Table A.12.1.--Estimate of Respondent Burden HCHS/SOL
----------------------------------------------------------------------------------------------------------------
Time per
Type of response Number of Number of response Burden
respondents responses (hours) (hours)
----------------------------------------------------------------------------------------------------------------
a. Recruitment contacts......................... 22,369 1 0.08 1,790
b. Household enumeration........................ 4,191 1 0.17 712
c. Telephone contact to set up appointment...... 6,667 1 0.08 533
d. Appointment Confirmation..................... 6,667 1 0.08 533
e. CLINIC EXAM:
e1. Procedures.............................. 5,333 1 3.67 19,572
e2. Questionnaires.......................... 5,333 1 2.75 14,666
f. Participant Telephone Interviews:
24-hour Dietary Intake Recall............... 5,333 1 0.67 3,573
Follow-Up Call.............................. 5,333 1 0.50 2,667
---------------------------------------------------------------
Total, Participant...................... 38,560 .............. .............. 44,046
===============================================================
Non-participant components: \1\
a. Physician, hospital and nursing home
contacts for outcomes ascertainment (total
= 1,254):
Deaths.................................. 60 1 0.50 627
CHF..................................... 90 .............. .............. ..............
Stroke.................................. 132 .............. .............. ..............
CHD..................................... 650 .............. .............. ..............
COPD.................................... 210 .............. .............. ..............
Asthma.................................. 112 .............. .............. ..............
b. Informant contact........................ 30 1 0.50 15
---------------------------------------------------------------
Total, Participant and Non-Participant 39,844 .............. .............. 44,688
Components.............................
----------------------------------------------------------------------------------------------------------------
\1\ Annual burden is place on physicians and health care providers and respondent relatives/informants through
request for information which will help in the compilation of the number and nature of new fatal and non-fatal
events.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Dr. Larissa Aviles-Santa, Deputy Project
Officer, NIH, NHLBI, 6701 Rockledge
[[Page 52155]]
Drive, MSC 7936, Bethesda, MD 20892-7936, or call non-toll-free number
301-435-1284 or E-mail your request, including your address to:
AvilessantaL@NHLBI.NIH.GOV.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: September 7, 2007.
Mike Lauer,
Director, Division of Prevention and Population Sciences, NHLBI,
National Institutes of Health.
Dated: September 7, 2007.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of Health.
[FR Doc. E7-17986 Filed 9-11-07; 8:45 am]
BILLING CODE 4140-01-P
