Submission for OMB Review; Comment Request; Pretesting of NIAID's HIV Vaccine Research Communications Messages, 67736-67737 [E7-23183]
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Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0019]
Guidance for Industry and Food and
Drug Administration Staff: Class II
Special Controls Guidance Document:
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Separation Principle;
Availability
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry and FDA Staff:
Class II Special Controls Guidance
Document: Automated Blood Cell
Separator Device Operating by
Centrifugal or Filtration Separation
Principle’’ dated November 2007. The
guidance document serves as the special
control for the automated blood cell
separator device operating on a
centrifugal or filtration separation
principle intended for the routine
collection of blood and blood
components, and describes a means by
which the device may comply with the
requirement of special controls for class
II devices. Elsewhere in this issue of the
Federal Register, FDA is publishing a
final rule to reclassify the automated
blood cell separator device operating by
centrifugal separation principle into
class II (special controls).
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance 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 self-addressed adhesive label
to assist the office in processing your
requests. 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 electronic access to the guidance
document.
Submit written comments on the
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 either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov.
VerDate Aug<31>2005
16:27 Nov 29, 2007
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Nathaniel L. Geary, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry and FDA Staff: Class II Special
Controls Guidance Document:
Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration
Separation Principle’’ dated November
2007. This special controls guidance
identifies the relevant classification
regulation that provides a description of
the applicable automated blood cell
separator device. In addition, other
sections of this special control guidance
list the risks to health identified by FDA
and describe measures that, if followed
by manufacturers and combined with
general controls, will ordinarily address
the risks associated with these
automated blood cell separators.
In the Federal Register of March 10,
2005 (70 FR 11990), FDA announced the
availability of the draft guidance of the
same title. FDA received one comment
on the proposed rule and draft guidance
and that comment was considered as the
rule and guidance were finalized. The
guidance announced in this notice
finalizes the draft guidance dated
January 2005.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. 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
requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This 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 (44 U.S.C. 3501–
3520). The collection of information in
this guidance was approved under OMB
control number 0910–0594.
III. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
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copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cber/guidelines.htm or
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23281 Filed 11–29–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Pretesting of
NIAID’s HIV Vaccine Research
Communications Messages
SUMMARY: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Allergy and Infectious
Diseases (NIAID), the National Institutes
of Health (NIH) has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on August 28, 2007, page 49282
and allowed 60-days for public
comment. One public comment was
received and was addressed in the OMB
request. The purpose of this notice is to
allow an additional 30 days for public
comment.
Proposed Collection: Title: Pretesting
of NIAID’s HIV Vaccine Research
Communications Messages. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
This is a request for clearance to pretest
messages, materials and program
activities produced for the NIAID HIV
Vaccine Research Education Initiative
(NHVREI). The primary objectives of the
pretests are to (1) assess audience
knowledge, attitudes, behaviors and
other characteristics for the planning/
development of health messages,
education products, communication
strategies, and public information
programs; and (2) pretest these health
messages, products, strategies, and
program components while they are in
E:\FR\FM\30NON1.SGM
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Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices
developmental form to assess audience
comprehension, reactions, and
perceptions. The information obtained
from audience research and pretesting
results in more effective messages,
materials, and programmatic strategies.
By maximizing the effectiveness of these
messages and strategies for reaching
targeted audiences, the frequency with
which publications, products, and
programs need to be modified is
reduced. Frequency of Response: On
occasion. Affected Public: Individuals.
Type of Respondents: Adults at risk for
HIV/AIDS, particularly those who are
Black/African-American, Hispanic/
Estimated
number of
respondents
Type of respondents
Latino, or men who have sex with men;
healthcare providers; representatives of
organizations disseminating HIV-related
messages or materials. The annual
reporting burden is shown in the table
below. There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Estimated
number of
responses per
respondent
Average
burden hours
per response
3,374
50
75
1
1
1
.3422
.75
.50
Total ......................................................................................................
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At-risk Adults ................................................................................................
Healthcare providers ....................................................................................
Organization Gatekeepers ...........................................................................
3,499
........................
..........................
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
Katharine Kripke, Assistant Director,
Vaccine Research Program, Division of
AIDS, NIAID, NIH, 6700B Rockledge
Dr., Bethesda, MD 20892–7628, or call
non-toll-free number 301–402–0846, or
VerDate Aug<31>2005
16:27 Nov 29, 2007
Jkt 214001
E-mail your request, including your
address to kripkek@niaid.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: November 7, 2007.
John J. McGowan,
Deputy Director for Science Management
NIAID.
[FR Doc. E7–23183 Filed 11–29–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Process Evaluation of the
Global Health Research Initiative
Program for New Foreign Investigators
(GRIP)
SUMMARY: In compliance with the
requirement of section 3506(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Fogarty International Center (FIC), 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: Process
evaluation of the Global Health
Research Initiative Program for New
Foreign Investigators (GRIP). Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
This study will assess the outputs of the
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Estimated
total annual
burden hours
requested
1,155
37.5
37.5
1,230
Global Health Research Initiative
Program for New Foreign Investigators
(GRIP) to date, assess the programs
alignment with new strategic goals of
the FIC, and identify potential
directions for program enhancement.
The primary objectives of the study are
to determine if GRIP awards (1) promote
productive re-entry of NIH-trained
foreign investigators into their home
countries, (2) increase the research
capacity of the international scientists
and institution, and (3) stimulate
research on a wide variety of high
priority health-related issues. The
findings will provide valuable
information concerning: (1) Specific
research advances attributable to GRIP
support; (2) specific capacity and career
enhancing advances that are attributable
to GRIP; (3) policy implications for GRIP
at the program level based on survey
responses, such as successes and
challenges of the program’s
implementation, the GRIP support
mechanism, etc. Frequency of Response:
Once. Affected Public: None. Type of
Respondents: Foreign researchers. The
annual reporting burden is as follows:
Estimated Number of Respondents: 101;
Estimated Number of Responses per
Respondent: 1; Average Burden Hours
Per Response: 0.50; and Estimated Total
Annual Burden Hours Requested: 50.5.
The annualized cost to respondents is
estimated at: $656.50. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report. Table 1 and Table 2 respectively
present data concerning the burden
hours and cost burdens for this data
collection.
E:\FR\FM\30NON1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67736-67737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23183]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Pretesting of NIAID's
HIV Vaccine Research Communications Messages
SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Allergy and Infectious
Diseases (NIAID), the National Institutes of Health (NIH) has submitted
to the Office of Management and Budget (OMB) a request to review and
approve the information collection listed below. This proposed
information collection was previously published in the Federal Register
on August 28, 2007, page 49282 and allowed 60-days for public comment.
One public comment was received and was addressed in the OMB request.
The purpose of this notice is to allow an additional 30 days for public
comment.
Proposed Collection: Title: Pretesting of NIAID's HIV Vaccine
Research Communications Messages. Type of Information Collection
Request: NEW. Need and Use of Information Collection: This is a request
for clearance to pretest messages, materials and program activities
produced for the NIAID HIV Vaccine Research Education Initiative
(NHVREI). The primary objectives of the pretests are to (1) assess
audience knowledge, attitudes, behaviors and other characteristics for
the planning/development of health messages, education products,
communication strategies, and public information programs; and (2)
pretest these health messages, products, strategies, and program
components while they are in
[[Page 67737]]
developmental form to assess audience comprehension, reactions, and
perceptions. The information obtained from audience research and
pretesting results in more effective messages, materials, and
programmatic strategies. By maximizing the effectiveness of these
messages and strategies for reaching targeted audiences, the frequency
with which publications, products, and programs need to be modified is
reduced. Frequency of Response: On occasion. Affected Public:
Individuals. Type of Respondents: Adults at risk for HIV/AIDS,
particularly those who are Black/African-American, Hispanic/Latino, or
men who have sex with men; healthcare providers; representatives of
organizations disseminating HIV-related messages or materials. The
annual reporting burden is shown in the table below. There are no
Capital Costs to report. There are no Operating or Maintenance Costs to
report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
At-risk Adults................................. 3,374 1 .3422 1,155
Healthcare providers........................... 50 1 .75 37.5
Organization Gatekeepers....................... 75 1 .50 37.5
----------------------------------------------------------------------------------------------------------------
Total...................................... 3,499 .............. .............. 1,230
----------------------------------------------------------------------------------------------------------------
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 Katharine Kripke, Assistant Director, Vaccine
Research Program, Division of AIDS, NIAID, NIH, 6700B Rockledge Dr.,
Bethesda, MD 20892-7628, or call non-toll-free number 301-402-0846, or
E-mail your request, including your address to kripkek@niaid.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: November 7, 2007.
John J. McGowan,
Deputy Director for Science Management NIAID.
[FR Doc. E7-23183 Filed 11-29-07; 8:45 am]
BILLING CODE 4140-01-P
