Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service; HIV Knowledge/Attitudes/Practice Customer Survey, 50036-50037 [E8-19479]
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ebenthall on PRODPC60 with NOTICES
50036
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices
determine appropriate dosing of cough
and cold ingredients in the pediatric
population? How should these studies
be designed and powered?
2. Should cough and cold products for
the pediatric population continue to be
available OTC, or should they be made
available only by prescription?
3. If the pediatric indications and
dosing for cough and cold products
were no longer available OTC, would
the public use the adult formulations of
the OTC monograph products for
children, and thus create a greater risk
of misuse or overdose?
4. Do the answers to the previous
questions depend on the age of the
pediatric patients? If so, how should age
be considered in making regulatory
decisions for these products?
5. At the time the monograph was
established, FDA routinely extrapolated
safety and efficacy data from adults to
children age 12 and over. Current PREA
standards permit extrapolation of
pediatric efficacy -- but not safety-based upon sufficient adult data. Does it
remain appropriate to recommend in the
cough and cold monograph that
children 12 and over should receive the
same dose of medication as adults,
without requiring any additional studies
in children in this age group? What
additional safety and/or efficacy studies
should be required in this age group?
6. What is the most appropriate
method for determining pediatric doses
that could be used as an alternative to
the quarter- and half-dose assumptions
used in the monograph? Should
products be dosed by age, by weight, or
both?
7. There are monographs for topical
and intranasal ingredients to treat the
common cold. Should these
monographs be considered in a similar
fashion to the oral cough and cold
products? Are the answers to the
previous questions different for any
subcategories of cough and cold
medicines (e.g., topical or intranasal
products)?
8. The CCABADP monograph allows
for the combination of ingredients to
treat colds and/or coughs. Should
combination products be permitted for
all pediatric age groups? Should data be
provided to support each unique
combination?
9. Can measurement errors in dosing
be reduced using more standardized
measuring devices or alternative dosage
forms and, if so, what is the best way
to effect this change?
III. Notice of Hearing Under 21 CFR
Part 15
The Commissioner is announcing that
the public hearing will be held in
VerDate Aug<31>2005
15:18 Aug 22, 2008
Jkt 214001
accordance with part 15 (21 CFR part
15). The hearing will be conducted by
a presiding officer, accompanied by
FDA senior management from the Office
of the Commissioner and the Center for
Drug Evaluation and Research.
Under § 15.30(f), the hearing is
informal, and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation. Public hearings under part
15 are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (part 10 (21 CFR part 10),
subpart C)). Under § 10.205,
representatives of the electronic media
may be permitted, subject to certain
limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b). To the extent that the
conditions for the hearing, as described
in this document, conflict with any
provisions set out in part 15, this
document acts as a waiver of those
provisions as specified in 21 CFR
15.30(h).
be available in either hard copy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic notices
of participation and comments for
consideration.
IV. Comments
Regardless of attendance at the public
hearing, interested persons may submit
written or electronic comments to the
Division of Dockets Management (see
ADDRESSES). Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments should be identified
with the docket number found in
brackets in the heading of this
document. To ensure consideration,
submit comments by (see DATES).
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 through FDMS only.
SUMMARY: In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires
60 days for public comment on
proposed information collection
projects, the Indian Health Service (IHS)
is publishing for comment a summary of
a proposed information collection to be
submitted to the Office of Management
and Budget (OMB) for review.
Proposed Collection: Title: 0917–
NEW, ‘‘Indian Health Service HIV
Knowledge/Attitudes/Practice Customer
Survey.’’ Type of Information Collection
Request: This is a one time survey to
deliver the mission of the IHS and
Centers for Disease Control (CDC)
national guidelines collection, 0917–
NEW, ‘‘Indian Health Service HIV
Knowledge/Attitudes/Practice Customer
Survey.’’ Form(s): The Indian Health
Service Customer Survey. Need and Use
of Information Collection:
The IHS goal is to raise the health
status of the American Indian and
Alaska Native (AI/AN) people to the
highest possible level by providing
comprehensive health care and
preventive health services. To support
the IHS mission, the Division of
Epidemiology and Disease Prevention
(DEDP) and the Human
Immunodeficiency Virus (HIV) Program
collaborate to provide programmatic,
technical, and financial assistance to
V. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Dated: August 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19657 Filed 8–22–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Proposed Information Collection:
Indian Health Service; HIV Knowledge/
Attitudes/Practice Customer Survey
Indian Health Service, HHS.
Notice.
AGENCY:
ACTION:
E:\FR\FM\25AUN1.SGM
25AUN1
50037
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices
IHS Areas and Service Units for
improving prevention, detection, and
treatment of infectious and chronic
disease, specifically in this case, HIV
and Sexually Transmitted Disease
(STD).
The ‘‘HIV Knowledge/Attitudes/
Practice Customer Survey’’ (hereto
referred to as Customer Survey), will
provide the information needed to
understand the most effective and
appropriate methods to complete these
goals. With the information collected
from patients, we will be able to offer
recommendations to Service Units on
how to best scale up screening for
sensitive topics such as HIV and STDs
in AI/AN communities. Also, the
information will give IHS the tools to
assist our Service Units with
implementation of current national
recommendations by CDC. At the
moment, we are encouraging uptake of
current CDC national recommendations;
however, without this information, we
are unable to maximize effectiveness,
dispel myths, and identify
misinformation.
Voluntary customer surveys will be
conducted through self-administered
questionnaires, face-to-face interviews,
and potentially electronic media. The
information gathered will be used by
DEDP and the HIV Program to identify
how patients would prefer to be offered
expanded testing in a way that is
respectful, confidential, and effective.
Affected Public: Individuals. Type of
Respondents: IHS customers.
The table below provides: Types of
data collection instruments, Estimated
number of respondents, Number of
responses per respondent, Average
burden hour per response, and Total
annual burden hour(s).
ESTIMATED BURDEN HOURS
Estimated
number of
respondents
Data collection instrument
Responses
per
respondent
Average
burden hour
per response
Total annual
burden hours
1000
1
10/60
166
Total ..........................................................................................................
ebenthall on PRODPC60 with NOTICES
Customer survey ..............................................................................................
1000
........................
........................
166
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Request for Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points: (a) Whether the information
collection activity is necessary to carry
out an agency function; (b) whether the
agency processes the information
collected in a useful and timely fashion;
(c) the accuracy of the public burden
estimate (the estimated amount of time
needed for individual respondents to
provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimates are logical; (e) ways to
enhance the quality, utility, and clarity
of the information being collected; and
(f) ways to minimize the public burden
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Send Comments and Requests for
Further Information: Send your written
comments, requests for more
information on the proposed collection,
or requests to obtain a copy of the data
collection instrument(s) and
instructions to: Ms. Janet Ingersoll,
Acting IHS Reports Clearance Officer,
801 Thompson Avenue, TMP 450,
Rockville, MD 20852–1627; call non-toll
free (301) 443–6177; send via facsimile
to (301) 443–2316; or send your E-mail
requests, comments, and return address
to: janet.ingersoll@ihs.gov.
Comment Due Date: Your comments
regarding this information collection are
best assured of having full effect if
VerDate Aug<31>2005
15:18 Aug 22, 2008
Jkt 214001
received within 60 days of the date of
this publication.
Dated: August 18, 2008.
Robert G. McSwain,
Director, Indian Health Service.
[FR Doc. E8–19479 Filed 8–22–08; 8:45 am]
BILLING CODE 4165–16–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Proposed Information Collection:
Indian Health Service; Health
Promotion/Disease Prevention Grantee
Survey
Indian Health Service, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires
60 days for public comment on
proposed information collection
projects, the Indian Health Service (IHS)
is publishing for comment a summary of
a proposed information collection to be
submitted to the Office of Management
and Budget (OMB) for review.
Proposed Collection: Title: 0917–
NEW, ‘‘Indian Health Service Health
Promotion/Disease Prevention Grantee
Survey.’’ Type of Information Collection
Request: This is a one time survey to
fulfill an OMB request for an
independent external evaluation
collection, 0917–NEW, ‘‘Indian Health
Service Health Promotion/Disease
Prevention (HP/DP) Grantee Survey.’’
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Form(s): The Indian Health Service HP/
DP Interview Survey. Need and Use of
Information Collection: The IHS goal is
to raise the health status of the
American Indian and Alaska Native (AI/
AN) people to the highest possible level
by providing comprehensive health care
and preventive health services. HP/DP
is one of the three IHS Director’s
Initiatives to reduce health disparities
among AI/AN populations through a
coordinated and systematic approach to
enhance health promotion and chronic
disease prevention approaches at the
local, regional, and national levels.
The HP/DP competitive grant was
established in 2005 to encourage Tribal
and urban Indian programs to fully
engage their local schools, communities,
health care providers, health centers,
faith-based/spiritual communities,
senior centers, youth programs, local
governments, academia, non-profit
organizations, and many other
community sectors to work together to
enhance and promote health and
prevent chronic disease in their
communities. Thirty-three Tribal/urban
Indian organizations and programs were
awarded competitive grants to expand
and enhance health promotion and
disease prevention to address health
disparities among AI/AN populations.
To conduct a thorough evaluation of
the grant program, 29 telephone and
four face-to-face interviews will be
conducted to collect information to
complete a quantitative and qualitative
evaluation of the HP/DP grant program.
The teleconference interviews may
include one staff member per site. Each
of the Tribal/urban organization/
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 73, Number 165 (Monday, August 25, 2008)]
[Notices]
[Pages 50036-50037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19479]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day Proposed Information
Collection: Indian Health Service; HIV Knowledge/Attitudes/Practice
Customer Survey
AGENCY: Indian Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires 60 days for public comment on
proposed information collection projects, the Indian Health Service
(IHS) is publishing for comment a summary of a proposed information
collection to be submitted to the Office of Management and Budget (OMB)
for review.
Proposed Collection: Title: 0917-NEW, ``Indian Health Service HIV
Knowledge/Attitudes/Practice Customer Survey.'' Type of Information
Collection Request: This is a one time survey to deliver the mission of
the IHS and Centers for Disease Control (CDC) national guidelines
collection, 0917-NEW, ``Indian Health Service HIV Knowledge/Attitudes/
Practice Customer Survey.'' Form(s): The Indian Health Service Customer
Survey. Need and Use of Information Collection:
The IHS goal is to raise the health status of the American Indian
and Alaska Native (AI/AN) people to the highest possible level by
providing comprehensive health care and preventive health services. To
support the IHS mission, the Division of Epidemiology and Disease
Prevention (DEDP) and the Human Immunodeficiency Virus (HIV) Program
collaborate to provide programmatic, technical, and financial
assistance to
[[Page 50037]]
IHS Areas and Service Units for improving prevention, detection, and
treatment of infectious and chronic disease, specifically in this case,
HIV and Sexually Transmitted Disease (STD).
The ``HIV Knowledge/Attitudes/Practice Customer Survey'' (hereto
referred to as Customer Survey), will provide the information needed to
understand the most effective and appropriate methods to complete these
goals. With the information collected from patients, we will be able to
offer recommendations to Service Units on how to best scale up
screening for sensitive topics such as HIV and STDs in AI/AN
communities. Also, the information will give IHS the tools to assist
our Service Units with implementation of current national
recommendations by CDC. At the moment, we are encouraging uptake of
current CDC national recommendations; however, without this
information, we are unable to maximize effectiveness, dispel myths, and
identify misinformation.
Voluntary customer surveys will be conducted through self-
administered questionnaires, face-to-face interviews, and potentially
electronic media. The information gathered will be used by DEDP and the
HIV Program to identify how patients would prefer to be offered
expanded testing in a way that is respectful, confidential, and
effective. Affected Public: Individuals. Type of Respondents: IHS
customers.
The table below provides: Types of data collection instruments,
Estimated number of respondents, Number of responses per respondent,
Average burden hour per response, and Total annual burden hour(s).
Estimated Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Average
Data collection instrument number of Responses per burden hour Total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Customer survey................................. 1000 1 10/60 166
---------------------------------------------------------------
Total....................................... 1000 .............. .............. 166
----------------------------------------------------------------------------------------------------------------
There are no Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
Request for Comments: Your written comments and/or suggestions are
invited on one or more of the following points: (a) Whether the
information collection activity is necessary to carry out an agency
function; (b) whether the agency processes the information collected in
a useful and timely fashion; (c) the accuracy of the public burden
estimate (the estimated amount of time needed for individual
respondents to provide the requested information); (d) whether the
methodology and assumptions used to determine the estimates are
logical; (e) ways to enhance the quality, utility, and clarity of the
information being collected; and (f) ways to minimize the public burden
through the use of automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
Send Comments and Requests for Further Information: Send your
written comments, requests for more information on the proposed
collection, or requests to obtain a copy of the data collection
instrument(s) and instructions to: Ms. Janet Ingersoll, Acting IHS
Reports Clearance Officer, 801 Thompson Avenue, TMP 450, Rockville, MD
20852-1627; call non-toll free (301) 443-6177; send via facsimile to
(301) 443-2316; or send your E-mail requests, comments, and return
address to: janet.ingersoll@ihs.gov.
Comment Due Date: Your comments regarding this information
collection are best assured of having full effect if received within 60
days of the date of this publication.
Dated: August 18, 2008.
Robert G. McSwain,
Director, Indian Health Service.
[FR Doc. E8-19479 Filed 8-22-08; 8:45 am]
BILLING CODE 4165-16-M
