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Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices

participating schools.6 Thus, the
incremental PRA burden for teachers
and students would be much less than
the estimates shown above.7 For
example, if only the time required to
take or administer the 20-minute test is
considered, the resulting total would be
a small fraction of the totals noted
above.
A few participating teachers (20–40)
also will take part in focus group
discussions, lasting approximately 90
minutes. The estimated teacher time in
focus groups, including an added hour
of round-trip transportation to and from
the discussion site, is 50–100 hours.
Finally, administering the study will
impose a small time burden on school
district staff charged with scoring the
tests and with compiling a master data
set of 8–12 year-old students, stripped
of personally identifiable information
(to facilitate random assignment to
treatment and control groups). These
programming and data management
tasks should take approximately 10–15
hours.
The cumulative burden for
participating students, teachers, and
school district staff for the Admongo
evaluation will total 34,300–45,769
hours. Again, however, the bulk of this
time would be subsumed within preexisting classroom requirements.

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C. Estimated Costs
The cost per respondent should be
negligible in both the evaluation and
focus group components of the study.
The participation of the school district
in the evaluation is voluntary, and the
district will use the Admongo program
to meet curriculum requirements. Thus,
participation in the evaluation study
will not impose any start-up, capital, or
labor expenditures beyond those
ordinarily incurred by the district to
administer curriculum units.
Participation by students in the
evaluation and teachers in the focus
groups also will be voluntary and not
impose any start-up, capital, or labor
expenditures. Teachers participating in
the focus groups will be compensated at
the standard rate paid by the contractor
to focus group participants. The school
district will be compensated for the cost
of the staff time to perform the data
management and test-scoring tasks.
D. Request for Comment
You can file a comment online or on
paper. For the Commission to consider
6 See

http://www.admongo.gov/state-standards/.
5 CFR 1320.3(b)(2)(A) (a collection of
information incurred by persons in the normal
course of their activities is excluded from ‘‘burden’’
to the extent that the activities necessary to comply
with it are ‘‘usual and customary’’).
7 See

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your comment, we must receive it on or
before September 4, 2012. Write
‘‘Admongo Evaluation, FTC File No.
P085200’’ on your comment. Your
comment—including your name and
your state—will be placed on the public
record of this proceeding, including, to
the extent practicable, on the public
Commission Web site, at http://
www.ftc.gov/os/publiccomments.shtm.
As a matter of discretion, the
Commission tries to remove individuals’
home contact information from
comments before placing them on the
Commission Web site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, like anyone’s Social
Security number, date of birth, driver’s
license number or other state
identification number or foreign country
equivalent, passport number, financial
account number, or credit or debit card
number. You are also solely responsible
for making sure that your comment does
not include any sensitive health
information, like medical records or
other individually identifiable health
information. In addition, don’t include
any ‘‘[t]rade secret or any commercial or
financial information which is obtained
from any person and which is privileged
or confidential,’’ as provided in Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2).
In particular, don’t include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you have to follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c).8 Your comment will be kept
confidential only if the FTC General
Counsel, in his or her sole discretion,
grants your request in accordance with
the law and the public interest.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
admongoevaluationPRA2, by following
8 In particular, the written request for confidential
treatment that accompanies the comment must
include the factual and legal basis for the request,
and must identify the specific portions of the
comment to be withheld from the public record. See
FTC Rule 4.9(c), 16 CFR 4.9(c).

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the instructions on the Web-based form.
If this Notice appears at http://
www.regulations.gov/#!home, you also
may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘Admongo Evaluation, FTC File
No. P085200’’ on your comment and on
the envelope, and mail or deliver it to
the following address: Federal Trade
Commission, Office of the Secretary,
Room H–113 (Annex J), 600
Pennsylvania Avenue NW., Washington,
DC 20580. If possible, submit your
paper comment to the Commission by
courier or overnight service.
Visit the Commission Web site at
http://www.ftc.gov to read this Notice
and the news release describing it. The
FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before September 4, 2012. You can find
more information, including routine
uses permitted by the Privacy Act, in
the Commission’s privacy policy, at
http://www.ftc.gov/ftc/privacy.htm.
Willard K. Tom,
General Counsel.
[FR Doc. 2012–18846 Filed 8–1–12; 8:45 am]
BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day 12–0840]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 and
send comments to Kim Lane, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email to [email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including

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Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Formative Research and Tool
Development—(OMB # 0920–0840, Exp.
3/31/2013)—Revision—National Center
for HIV/AIDS, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention request approval to collect
formative research and tool
development data over a three-year
period. This information collection
request has been revised to include one
additional type of formative research
information collection activity,
additional detail regarding the
previously approved categories of
formative research, and instrument
testing for data collection activities used
to inform many aspects of surveillance,
communications, health promotion, and
research project development for
NCHHSTP’s four priority diseases (HIV/
AIDS, sexually transmitted diseases/
infections (STD/STI), viral hepatitis,
and tuberculosis elimination).
Formative research is the basis for
developing effective strategies including
communication channels, for
influencing behavior change. It helps
researchers identify and understand the
characteristics (interests, behaviors and
needs) of target populations that
influence their decisions and actions.
Formative research is research that
occurs before a program is designed and
implemented, or while a program is
being conducted and is and is integral
in developing programs as well as

This request also includes collection
of information from public health
programs to assess needs related to
initiation of a new program activity or
expansion or changes in scope or
implementation of existing program
activities to adapt them to current
needs. The information collected will be
used to advise programs and provide
capacity-building assistance tailored to
identified needs.
Overall, these development activities
are intended to provide information that
will increase the success of the
surveillance or research projects
through increasing response rates and
decreasing response error, thereby
decreasing future data collection burden
to the public. The studies that will be
covered under this request will consist
of healthcare providers and the general
public as respondents and will include
one or more of the following
investigational modalities: (1)
Structured and qualitative interviewing
for surveillance, research, interventions
and material development, (2) cognitive
interviewing for development of specific
data collection instruments, (3)
methodological research, (4) usability
testing of technology-based instruments
and materials, (5) field testing of new
methodologies and materials, (6)
investigation of mental models for
health decision-making, to inform
health communication messages, and (7)
organizational needs assessment to
support development of capacity.
Respondents who will participate in
individual and group interviews
(qualitative, cognitive, and computer
assisted development activities) are
selected purposively from those who
respond to recruitment advertisements.
In addition to utilizing advertisements
for recruitment, respondents who will
participate in research on survey
methods may be selected purposively or
systematically from within an ongoing
surveillance or research project.
Participation of respondents is
voluntary.
There is no cost to participants other
than their time.

improving existing and ongoing
programs. Formative research also looks
at the community in which a public
health intervention is being or will be
implemented and helps the project staff
understand the interests, attributes and
needs of different populations and
persons in that community.
Formative research is also an integral
part of adapting programs that deal with
the complexity of behaviors, social
context, cultural identities, and health
care that underlie the epidemiology of
HIV/AIDS, viral hepatitis, STDs, and
tuberculosis (TB) in the U.S.
CDC conducts formative research to
develop public-sensitive
communication messages and userfriendly tools prior to developing or
recommending interventions, or care.
Sometimes these studies are entirely
behavioral but most often they are
cycles of interviews and focus groups
designed to inform the development of
a product.
Products from these formative
research studies will be used for
prevention of HIV/AIDS, Sexually
Transmitted Infections (STI), viral
Hepatitis, and Tuberculosis. Findings
from these studies may also be
presented as evidence to diseasespecific National Advisory Committees,
to support revisions to recommended
prevention and intervention methods, as
well as new recommendations.
Much of CDC’s health communication
takes place within campaigns that have
fairly lengthy planning periods—
timeframes that accommodate the
standard Federal process for approving
data collections.
This request includes studies
investigating the utility and
acceptability of proposed sampling and
recruitment methods, intervention
contents and delivery, questionnaire
domains, individual questions, and
interactions with project staff or
electronic data collection equipment.
These activities will also provide
information about how respondents
answer questions and ways in which
question response bias and error can be
reduced.

ESTIMATED ANNUALIZED BURDEN HOURS

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Type of respondent
General
General
General
General
General

public
public
public
public
public

health
health
health
health
health

care
care
care
care
care

Average hours
per response

Total response
burden
(hours)

Screener .......................
Consent Forms .............
Individual interview .......
Group interview ............
Survey of Individual ......

97440
48720
7920
4800
36000

1
1
1
1
1

10/60
5/60
1
2
30/60

16240
4060
7920
9600
18000

Total ...............................................................

.......................................

194880

........................

........................

55820

18:15 Aug 01, 2012

providers
providers
providers
providers
providers

Number of
responses per
respondent

............
............
............
............
............

VerDate Mar<15>2010

and
and
and
and
and

Number of
respondents

Form name

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46096

Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices

Kimberly S. Lane,
Deputy Director, Office of Science Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012–18851 Filed 8–1–12; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors, Office
of Public Health Preparedness and
Response (BSC, OPHPR)

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In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Times and Dates:
9:30 a.m.–3 p.m., August 21, 2012; 9:30
a.m.–3 p.m., August 22, 2012.
Place: CDC, 1600 Clifton Road NE., Roybal
Campus, Building 19, Auditorium B2,
Atlanta, Georgia 30329.
Status: Open to the public limited only by
the space available. The meeting room will
accommodate up to 30 people. Public
participants should pre-register for the
meeting as described in Additional
Information for Public Participants.
Purpose: This Board is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services (HHS), the Assistant Secretary for
Health (ASH), the Director, Centers for
Disease Control and Prevention (CDC), and
the Director, Office of Public Health
Preparedness and Response (OPHPR),
concerning strategies and goals for the
programs and research within OPHPR,
monitoring the overall strategic direction and
focus of the OPHPR Divisions and Offices,
and administration and oversight of peer
review of OPHPR scientific programs. For
additional information about the Board,
please visit: http://www.cdc.gov/phpr/
science/counselors.htm.
Matters to be Discussed: Agenda items for
this meeting include: (1) Briefings and BSC
deliberation on the following topics: OPHPR
International Activities; National Health
Security Preparedness Index Update; update
on the activities of the joint BSC-National
Biodefense Science Board Strategic National
Stockpile ad hoc working group; CDC’s
response to laboratory biosafety issues;
Public Health Emergency Medical
Countermeasure Enterprise (PHEMCE) and
CDC’s smallpox vaccine program; OPHPR’s
national policy initiatives; history and
overview of the Preparedness and Emergency
Response Learning Centers; update on CDC’s
biosurveillance and situational awareness
activities; (2) BSC liaison representative
updates to the Board highlighting
organizational activities relevant to the
OPHPR mission.

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Agenda items are subject to change as
priorities dictate.
Additional Information for Public
Participants: Members of the public that wish
to attend this meeting should pre-register by
submitting the following information by
email, facsimile, or phone (see Contact
Person for More Information) no later than 12
noon (EDT) on Monday, August 13, 2012:
• Full Name,
• Organizational Affiliation,
• Complete Mailing Address,
• Citizenship, and
• Phone Number or Email Address.
Contact Person for More Information:
Marquita Black, Office of Science and Public
Health Practice Executive Assistant, Centers
for Disease Control and Prevention, 1600
Clifton Road NE., Mailstop D–44, Atlanta,
Georgia 30333, telephone (404) 639–7325;
facsimile (404) 639–7977; email:
[email protected].
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: July 27, 2012.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2012–18852 Filed 8–1–12; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA–2012–N–0001]

Statistical Process Controls for Blood
Establishments; Public Workshop
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of public workshop.

The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Statistical Process Controls for
Blood Establishments.’’ The purpose of
this public workshop is to discuss the
implementation of statistical process
controls to validate and monitor
manufacturing processes in blood
establishments. The public workshop
has been planned in partnership with
the AABB, America’s Blood Centers,
and the Department of Health and
Human Services (HHS) Office of the
Assistant Secretary for Health. The
public workshop will include
presentations and discussions led by
experts from government and industry.
Dates and Times: The public
workshop will be held on October 19,
2012, from 8:30 a.m. to 5 p.m.

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Location: The public workshop will
be held at the FDA White Oak Campus,
The Great Room, Bldg. 31, 10903 New
Hampshire Ave. Silver Spring, MD,
20993. Please visit the following Web
site for location, parking, security, and
travel information: http://www.fda.gov/
AboutFDA/WorkingatFDA/
BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. The public workshop
will also be available to be viewed
online via webcast.
Streaming Webcast of the Public
Workshop: For those unable to attend in
person, FDA will webcast the public
workshop. To join the web-cast of the
public workshop, please go to: https://
collaboration.fda.gov/stat101912/.
If you have never attended a Connect
Pro meeting before: Test your
connection: https://collaboration.fda.
gov/common/help/en/support/meeting_
test.htm. Get a quick overview: http://
www.adobe.com/go/connectpro_
overview.
Contact Person: Jennifer Scharpf,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6128, FAX: 301–827–2843,
email:
[email protected].
Registration: Mail, fax, or email your
registration information (including
name, title, firm name, address,
telephone and fax numbers, and email
address) to Jennifer Scharpf (see Contact
Person) by September 27, 2012. Please
indicate if you will attend the workshop
in person or if you will participate in
the webcast. There is no registration fee
for the public workshop. Early
registration is recommended because
seating is limited. Those who wish to
present at the workshop must attend in
person. Registration on the day of the
public workshop will be provided on a
space-available basis beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact
Jennifer Scharpf (see Contact Person) at
least 7 days in advance.
Requests for Oral Presentations:
Interested persons are invited to make
presentations relevant to the public
workshop topic. Attendees who wish to
make presentations at the public
workshop should notify the Contact
Person and submit a brief statement of
the general nature of the presentation
before September 27, 2012.
Presentations will be scheduled on the
afternoon of October 19, 2012. Time
allotted for each presentation may be
limited depending on the number of
individuals requesting to speak.

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