Agency Forms Undergoing Paperwork Reduction Act Review, 62480-62481 [E7-21666]
Download as PDF
<![CDATA[
62480
Federal Register / Vol. 72, No. 213 / Monday, November 5, 2007 / Notices
represented and the committee’s
function. Every effort is made that a
broad representation of geographic
areas, gender, ethnic and minority
groups, and the disabled are given
consideration for membership on HHS
Federal advisory committees.
Appointment to this committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status.
The Standards of Ethical Conduct for
Employees of the Executive Branch are
applicable to individuals who are
appointed as public members of Federal
advisory committees. Individuals
appointed to serve as public members of
Federal advisory committees are
classified as special Government
employees (SGEs). SGEs are
Government employees for purposes of
the conflict of interest laws. Therefore,
individuals appointed to serve as public
members of NVAC are subject to an
ethics review. The ethics review is
conducted to determine if the
individual has any interests and/or
activities in the private sector that may
conflict with performance of their
official duties as a member of the
Committee. Individuals appointed to
serve as public members of the
Committee will be required to disclose
information regarding financial
holdings, consultancies, and research
grants and/or contracts.
Dated: October 30, 2007.
Bruce Gellin,
Director, National Vaccine Program Office,
Executive Secretary, National Vaccine
Advisory Committee.
[FR Doc. E7–21682 Filed 11–2–07; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–08–07AL]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call 404–639–5960 or send an
e-mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC, or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Notice of Correction to Burden Table
Proposed Project
Evaluation of the Successful Business
Strategies to Prevent Heart Disease and
Stroke Toolkit—NEW—Division for
Heart Disease and Stroke Prevention
(DHDSP), National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Description of Correction
The previous 30-day Federal Register
Notice (FRN) published August 31,
2007, Volume 72, No. 169, Pages 50371–
50372, was submitted with an error
showing the number of respondents as
51. This correction reduces the number
of respondents from 51 to 25.
Background and Brief Description
Under Part C (Centers for Disease
Control and Prevention) of the
Statement of Organization Functions,
and Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 70 FR 72842–72843,
dated December 7, 2005), the Division
for Heart Disease and Stroke Prevention,
National Center for Chronic Disease
Prevention and Health Promotion,
Centers for Disease Control and
Prevention was established. This
Division plans, directs, and coordinates
programs to reduce morbidity, risk
factors, costs, disability, mortality, and
disparities associated with heart
disease, stroke, and other cardiovascular
disease outcomes. Under this Division,
formative research was conducted to
identify effective interventions and
promising practices for preventing heart
disease and stroke at the work site. In
2005, this research resulted in the
development of a Successful Business
Strategies to Prevent Heart Disease and
Stroke Toolkit. The toolkit provides
state programs with suggestions about
which health benefits, services, and
interventions can improve employee
cardiovascular health, prevent heart
disease and stroke, and reduce related
costs. The second phase of this project
focuses on disseminating and evaluating
the Successful Business Strategies to
Prevent Heart Disease and Stroke
Toolkit.
As part of the Toolkit evaluation, the
CDC has employed contractor support to
design and conduct a Web-based survey
of State Health Departments to gather
information on their experiences with
the Toolkit. The contractor will collect
and analyze all data from this survey.
The CDC has also contracted to make
revisions to the toolkit based on results
of this survey, ongoing feedback from
the States, and feedback from employers
through interviews. The Centers for
Disease Control and Prevention (CDC) is
seeking a 6-month Office of
Management and Budget (OMB)
approval for implementing the Webbased survey.
There are no costs to respondents
except for their time to complete the
survey. The total estimated annualized
burden hours are 13.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
State Heart Disease and Stroke Programs ....
ycherry on PRODPC74 with NOTICES
Type of respondents
Web-based survey on CVH Toolkit ...............
VerDate Aug<31>2005
17:17 Nov 02, 2007
Jkt 214001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
E:\FR\FM\05NON1.SGM
Number of
responses per
respondent
25
05NON1
1
Average
burden per
response
(in hrs.)
30/60
Federal Register / Vol. 72, No. 213 / Monday, November 5, 2007 / Notices
Dated: October 25, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–21666 Filed 11–2–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0412]
Adolescent Over-the-Counter Drug
Product Use; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA), the National
Institutes of Health (NIH), and the
Consumer Healthcare Product
Association (CHPA) are announcing a
public workshop entitled ‘‘Adolescent
Over-the-Counter (OTC) Drug Product
Use.’’ The purpose of the workshop is
to gain an understanding of current use
of OTC drug products by adolescents,
including adolescent decisionmaking
skills (compared with adult skills) and
other factors influencing adolescent
OTC drug product use. Information
gathered at the workshop and from
submitted comments will be used to
identify when it would be most
appropriate for consumer studies on
OTC drugs to enroll adolescents, and to
define the type of consumer research
and study designs needed to support
OTC drug product approval in the
adolescent population. The workshop is
intended to help inform FDA in its
effort to assure the safe and effective use
of OTC drug products by adolescents.
DATES: The public workshop will be
held on December 6, 2007, from 8:30
a.m. to 5:30 p.m. and on December 7,
2007, from 8:30 a.m. to 3:30 p.m.
Register to make an oral presentation
during the open public session by
November 21, 2007. Submit written or
electronic comments by January 31,
2008.
The public workshop will
be held at the Natcher Conference
Center, National Institutes of Health, 45
Center Dr., Bethesda, MD 20892.
Submit written comments 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.fda.gov/ohrms/dockets/
ecomments.
ycherry on PRODPC74 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
15:04 Nov 02, 2007
Jkt 214001
FOR FURTHER INFORMATION CONTACT:
Faith Dugan, Center for Drug Evaluation
and Research (HFD–6), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–6779,
FAX: 301–827–4312, e-mail:
Faith.Dugan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
We are announcing a public
workshop on adolescent use of OTC
drug products. OTC drugs are FDAregulated drug products that are
available without a prescription. Other
health care products (e.g., dietary
supplements) are beyond the scope of
the workshop. Adolescents use OTC
drug products from a wide range of
therapeutic categories (including
fluoride toothpastes, acne drug
products, and pain relievers) and with
varying degrees of parental oversight.
While clinical and consumer behavior
studies for OTC drugs have enrolled
various populations, few studies have
included adolescents. Therefore, limited
information on adolescents’ use of OTC
drug products has been collected
regarding the magnitude of their use, the
types of products they use, factors that
influence their use, or their ability to
understand and follow directions
provided on OTC labels.
The desire to learn more about
adolescent decisionmaking skills as they
relate to the use of OTC drug products
has generated interest in holding a
public workshop that would convene a
group of scientific experts and solicit
input from the public. Information
gathered at the workshop would help
identify methods for assessing
adolescent OTC drug use and identify
information useful to regulatory
decisionmaking.
II. Why Are We Holding This Public
Workshop?
This workshop has been developed to
further our understanding of the
physiological and psychological
differences and similarities between
adolescents and adults, which may have
an impact on adolescents’ decisions
about OTC drug use and also may define
research priorities for assessing the
differences in drug use decisions. The
workshop is also aimed at designing
efforts to encourage appropriate OTC
drug product use by adolescents. It is
hoped that such efforts will foster
appropriate use when adolescents
become adults.
III. What Are the Topics We Intend to
Address at the Workshop?
We will address the following topics
at the workshop:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
62481
• OTC drug product use by
adolescents;
• Discussion of adolescent
neurocognitive development and
decisionmaking skills;
• Discussion of how best to
communicate product information
directed toward adolescents;
• Discussion of future actions and
research agendas, including studies
regarding consumer behavioral issues;
and
• Discussion of mechanisms to
promote appropriate and optimal use of
OTC drugs by adolescents.
We are interested in hearing
comments at the public workshop or
receiving written or electronic
comments (see section V of this
document) on the following questions:
1. What is known about current OTC
drug product use by adolescents? Focus
on the following information:
• Magnitude of current use of OTC
drugs by adolescents;
• Product categories commonly used
by adolescents;
• Market use data for such drugs;
• Consumer behavior studies that
have enrolled adolescents; and
• Factors that influence adolescent’s
use of OTC products, such as drug class,
age, parental involvement and
influence, household dynamics, social
circumstances, and gender.
2. How does adolescent neurocognitive
development influence decisionmaking
and behavior as they relate to OTC drug
product use?
• Identify known factors that
contribute to how adolescents make
health-related decisions;
• Discuss adolescent behavior
patterns, decisionmaking skills, and
predictors of risk-taking behavior as
they relate to purchase and use of OTC
drugs; and
• Discuss differences between
adolescent and adult risk perceptions
and decisionmaking and discuss the
ages at which identifiable
developmental transitions generally
occur.
3. What future actions will help
promote safe and effective use of OTC
drugs by adolescents?
• Discuss drug categories (e.g.,
analgesics, acne drugs) for which it
would be appropriate to enroll
adolescents in clinical and behavioral
studies and identify related study
design issues (e.g., design, age, informed
consent, parental assent, compliance);
• Assess the need for consumer
behavior studies targeted toward
adolescents;
• Explore alternate and effective
means of communicating with
adolescents, including need for labels
E:\FR\FM\05NON1.SGM
05NON1
]]>Agencies
[Federal Register Volume 72, Number 213 (Monday, November 5, 2007)]
[Notices]
[Pages 62480-62481]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21666]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-08-07AL]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
404-639-5960 or send an e-mail to omb@cdc.gov. Send written comments to
CDC Desk Officer, Office of Management and Budget, Washington, DC, or
by fax to (202) 395-6974. Written comments should be received within 30
days of this notice.
Notice of Correction to Burden Table
Proposed Project
Evaluation of the Successful Business Strategies to Prevent Heart
Disease and Stroke Toolkit--NEW--Division for Heart Disease and Stroke
Prevention (DHDSP), National Center for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention
(CDC).
Description of Correction
The previous 30-day Federal Register Notice (FRN) published August
31, 2007, Volume 72, No. 169, Pages 50371-50372, was submitted with an
error showing the number of respondents as 51. This correction reduces
the number of respondents from 51 to 25.
Background and Brief Description
Under Part C (Centers for Disease Control and Prevention) of the
Statement of Organization Functions, and Delegations of Authority of
the Department of Health and Human Services (45 FR 67772-76, dated
October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as
amended most recently at 70 FR 72842-72843, dated December 7, 2005),
the Division for Heart Disease and Stroke Prevention, National Center
for Chronic Disease Prevention and Health Promotion, Centers for
Disease Control and Prevention was established. This Division plans,
directs, and coordinates programs to reduce morbidity, risk factors,
costs, disability, mortality, and disparities associated with heart
disease, stroke, and other cardiovascular disease outcomes. Under this
Division, formative research was conducted to identify effective
interventions and promising practices for preventing heart disease and
stroke at the work site. In 2005, this research resulted in the
development of a Successful Business Strategies to Prevent Heart
Disease and Stroke Toolkit. The toolkit provides state programs with
suggestions about which health benefits, services, and interventions
can improve employee cardiovascular health, prevent heart disease and
stroke, and reduce related costs. The second phase of this project
focuses on disseminating and evaluating the Successful Business
Strategies to Prevent Heart Disease and Stroke Toolkit.
As part of the Toolkit evaluation, the CDC has employed contractor
support to design and conduct a Web-based survey of State Health
Departments to gather information on their experiences with the
Toolkit. The contractor will collect and analyze all data from this
survey. The CDC has also contracted to make revisions to the toolkit
based on results of this survey, ongoing feedback from the States, and
feedback from employers through interviews. The Centers for Disease
Control and Prevention (CDC) is seeking a 6-month Office of Management
and Budget (OMB) approval for implementing the Web-based survey.
There are no costs to respondents except for their time to complete
the survey. The total estimated annualized burden hours are 13.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hrs.)
----------------------------------------------------------------------------------------------------------------
State Heart Disease and Stroke Web-based survey on CVH 25 1 30/60
Programs. Toolkit.
----------------------------------------------------------------------------------------------------------------
[[Page 62481]]
Dated: October 25, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E7-21666 Filed 11-2-07; 8:45 am]
BILLING CODE 4163-18-P
