Submission for OMB Review; Comment Request; The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL), 75725-75726 [E8-29427]
Download as PDF
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
jlentini on PROD1PC65 with NOTICES
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health
(CDRH), Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850
or to the Office of Communication,
Training, and Manufacturers Assistance
(HFM–40), Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to CDRH at 240–276–3151.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Steven Turtil, Center for Devices and
Radiological Health (HFZ–480),
Food and Drug Administration,
9200 Corporate Blvd., Rockville,
MD 20850, 240–276–3747;
Chiu Lin, Center for Devices and
Radiological Health (HFZ–480), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3700; or
Leonard Wilson, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852
301–827–0373.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document
updates and clarifies the procedures for
reviewing premarket notification
submissions (510(k)s) for devices
labeled as sterile, particularly with
respect to sterilization technologies FDA
considers novel. The draft guidance
provides details about the pyrogenicity
information we recommend be included
in 510(k)s for devices labeled as sterile.
When final, this draft will supersede the
guidance entitled ‘‘Updated 510(k)
Sterility Review Guidance K90–1’’ that
FDA issued on August 30, 2002
(available at https://www.fda.gov/cdrh/
ode/guidance/361.pdf).
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
VerDate Aug<31>2005
17:56 Dec 11, 2008
Jkt 217001
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on premarket notification submissions
for devices labeled as sterile. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘Submission
and Review of Sterility Information in
Premarket Notification (510(k))
Submissions for Devices Labeled as
Sterile,’’ you may either send an e-mail
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 240–
276–3151 to receive a hard copy. Please
use the document number 1615 to
identify the guidance you are
requesting.
CDRH maintains an entry on the
Internet for easy access to information,
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the CBER Internet site at https://
www.fda.gov/cber/guidelines.htm or the
Division of Dockets Management
Internet site at https://
www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520). This
draft guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by OMB under the PRA. The
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
75725
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) 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 with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29413 Filed 12–11–08; 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 the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on October 3, 2008, page
57634, and allowed 60 days for public
comment. One comment was received.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
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
E:\FR\FM\12DEN1.SGM
12DEN1
75726
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
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, sixand-a-half year epidemiologic study and
will recruit 16,000 Hispanic men and
women aged 18–74 in four communitybased cohorts in Chicago, Miami, San
Diego, and the Bronx. The study will
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: 30,401; Estimated Number
of Responses per Respondent: 2.234;
Average Burden Hours Per Response:
0.7178; and Estimated Total Annual
Burden Hours Requested: 48,755. The
annualized cost to respondents is
estimated at $756,412, 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.
ESTIMATE OF ANNUAL HOUR BURDEN
Type of
response
Number of respondents
Participant Recruitment Contact ....................................................................
Participant Examinations and Questionnaires ...............................................
Participant Telephone Interviews ..................................................................
Physician, Medical Examiner, next of kin or other contact follow-up [2] ........
Focus Groups ................................................................................................
29,036
5,333[1]
5,333[1]
1,284
81
Total unique respondents .......................................................................
Frequency of
responses
Average hours
per response
1
1
1
1
1
Annual hour
burden
0.123
6.49
1.83
.50
1.5
30,401
3,571
34,611
9,759
642
121
48,755
[1] Subset
jlentini on PROD1PC65 with NOTICES
of participant recruitment contact.
[2] Annual burden is placed on doctors and respondent relatives/informants through requests for information which will help in the compilation of
the number and nature of new fatal and nonfatal 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,
VerDate Aug<31>2005
17:56 Dec 11, 2008
Jkt 217001
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, 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: Ms. Lorraine
Silsbee, Deputy Project Officer, NIH,
NHLBI, 6701 Rockledge Drive, MSC
7936, Bethesda, MD 20892–7936, or call
non-toll-free number 301–435–0709 or
E-mail your request, including your
address to: silsbeeL@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: December 2, 2008.
Michael S. Lauer,
Director, Division of Prevention and
Population Sciences, NHLBI, National
Institutes of Health.
Dated: December 3, 2008.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of
Health.
[FR Doc. E8–29427 Filed 12–11–08; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; F05 K 21
Fellowships.
Date: December 10–11, 2008.
Time: 8 a.m. to 5 p.m.
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Notices]
[Pages 75725-75726]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29427]
-----------------------------------------------------------------------
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
the information collection listed below. This proposed information
collection was previously published in the Federal Register on October
3, 2008, page 57634, and allowed 60 days for public comment. One
comment was received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may 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
[[Page 75726]]
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 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: 30,401; Estimated Number of Responses
per Respondent: 2.234; Average Burden Hours Per Response: 0.7178; and
Estimated Total Annual Burden Hours Requested: 48,755. The annualized
cost to respondents is estimated at $756,412, 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.
Estimate of Annual Hour Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average hours Annual hour
Type of response respondents responses per response burden
----------------------------------------------------------------------------------------------------------------
Participant Recruitment Contact................. 29,036 1 0.123 3,571
Participant Examinations and Questionnaires..... 5,333\[1]\ 1 6.49 34,611
Participant Telephone Interviews................ 5,333\[1]\ 1 1.83 9,759
Physician, Medical Examiner, next of kin or 1,284 1 .50 642
other contact follow-up \[2]\..................
Focus Groups.................................... 81 1 1.5 121
---------------------------------------------------------------
Total unique respondents.................... 30,401 .............. .............. 48,755
----------------------------------------------------------------------------------------------------------------
\[1]\ Subset of participant recruitment contact.
\[2]\ Annual burden is placed on doctors and respondent relatives/informants through requests for information
which will help in the compilation of the number and nature of new fatal and nonfatal 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
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: Ms.
Lorraine Silsbee, Deputy Project Officer, NIH, NHLBI, 6701 Rockledge
Drive, MSC 7936, Bethesda, MD 20892-7936, or call non-toll-free number
301-435-0709 or E-mail your request, including your address to:
silsbeeL@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: December 2, 2008.
Michael S. Lauer,
Director, Division of Prevention and Population Sciences, NHLBI,
National Institutes of Health.
Dated: December 3, 2008.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of Health.
[FR Doc. E8-29427 Filed 12-11-08; 8:45 am]
BILLING CODE 4140-01-P