Att 2_60dyFRN

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Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices

Proposed Project
Aggregate Reports for Tuberculosis
Program Evaluation (0920–0457—Exp.
9–30–2016)—Extension—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC)
Background and Brief Description
CDC requests the extension of the
Aggregate Reports for Tuberculosis
Program Evaluation, previously
approved under OMB No. 0920–0457
for 3-years. There are no revisions to the
report forms, data definitions, or
reporting instructions.
To ensure the elimination of
tuberculosis in the United States, CDC
monitors indicators for key program
activities, such as finding tuberculosis

infections in recent contacts of cases
and in other persons likely to be
infected and providing therapy for
latent tuberculosis infection. In 2000,
CDC implemented two program
evaluation reports for annual
submission: Aggregate report of followup for contacts of tuberculosis, and
Aggregate report of screening and
preventive therapy for tuberculosis
infection (OMB No. 0920–0457). The
respondents for these reports are the 68
state and local tuberculosis control
programs receiving federal cooperative
agreement funding through the CDC
Division of Tuberculosis Elimination
(DTBE). These reports emphasize
treatment outcomes, high-priority target
populations vulnerable to tuberculosis,
and programmed electronic report entry,
which transitioned to the National
Tuberculosis Indicators Project (NTIP), a

secure web-based system for program
evaluation data, in 2010. No other
federal agency collects this type of
national tuberculosis data, and the
Aggregate report of follow-up for
contacts of tuberculosis, and Aggregate
report of screening and preventive
therapy for tuberculosis infection are
the only data source about latent
tuberculosis infection for monitoring
national progress toward tuberculosis
elimination with these activities. CDC
provides ongoing assistance in the
preparation and utilization of these
reports at the local and state levels of
public health jurisdiction. CDC also
provides respondents with technical
support for the NTIP software
(Electronic—100%, Use of Electronic
Signatures—No). There is no cost to
respondents.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Form name

Data clerks and Program Managers, electronic.
Program Managers, manual .....................

Follow-up and Treatment of Contacts to
Tuberculosis Cases Form (Att 3a).
Follow-up and Treatment of Contacts to
Tuberculosis Cases Form (Att 3a).
Follow-up and Treatment of Contacts to
Tuberculosis Cases Form (Att 3a).
Targeted Testing and Treatment for Latent Tuberculosis Infection (Att 3b).
Targeted Testing and Treatment for Latent Tuberculosis Infection (Att 3b).
Targeted Testing and Treatment for Latent Tuberculosis Infection (Att 3b).

Data clerks, (manual) ................................
Data clerks and Program Managers, electronic.
Program Managers, (manual) ...................
Data clerks, (manual) ................................
Total ...................................................

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

Jeffrey M. Zirger,
Health Scientist, Acting Chief, Information
Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for
Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2016–15647 Filed 6–30–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Centers for Disease Control and
Prevention
[60Day–16–16ATI; Docket No. CDC–2016–
0057]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Number of
responses per
respondent

100

1

30/60

50

18

1

30/60

9

18

1

3

54

100

1

30/60

50

18

1

30/60

9

18

1

3

54

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

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

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226

Notice with comment period.

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on Development of CDC’s Act
Against AIDS Social Marketing
Campaigns Targeting Consumers. CDC
is requesting approval for revision to the
previously approved project to continue
testing HIV/AIDS prevention and
treatment messages to be included in
social marketing campaigns targeting
consumers.

SUMMARY:

Written comments must be
received on or before August 30, 2016.

DATES:

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Average
burden per
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Number of
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Total
burden
hours

You may submit comments,
identified by Docket No. CDC–2016–
0057 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.

ADDRESSES:

Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.

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43205

Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
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; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
FOR FURTHER INFORMATION CONTACT:

of all races. All campaigns support the
comprehensive HIV prevention efforts
of CDC and the National HIV/AIDS
Strategy (NHAS).
The goal of this study is to
qualitatively test messages and materials
that will be used in specific HIV social
marketing campaigns under the AAA
initiative that target consumers in order
to increase HIV testing rates, increase
HIV awareness and knowledge,
challenge commonly held
misperceptions about HIV, and promote
HIV prevention and risk reduction. The
intended use of the resulting data is for
CDC to revise and/or develop timely,
relevant, clear, and engaging materials
for these social marketing campaigns.
Qualitative methods will be used to
collect the data include focus groups,
intercept interviews, and in-depth
interviews. Qualitative methods provide
flexible in-depth exploration of the
participants’ perceptions and
experience; and the interviews yield
descriptions in the participants’ own
words. Qualitative methods also allow
the interviewer flexibility to pursue
relevant and important issues as they
arise during the discussion.
The participants will also participate
in a brief 15-minute brief survey. Data
collected by the brief survey will
provide a source of quantitative data
supplementing the qualitative data
collected during the interviews. The
brief survey will be administered to
participants before the individual indepth interview and focus group. The
survey will collect basic background
information about the participants’
knowledge, attitudes and beliefs about
HIV, HIV testing behaviors, risk
behaviors and demographics to enable
us to more fully describe the
participants.
There is no cost to participants other
than their time. The total estimated
annualized burden hours are 2,063.

the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Development of CDC’s Act Against AIDS
Social Marketing Campaigns Targeting
Consumers—New—National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC)
Background and Brief Description
In an effort to refocus attention on
domestic HIV and AIDS, CDC launched
the Act Against AIDS (AAA) initiative
in 2009 with the White House and the
U.S. Department of Health and Human
Services. AAA is a multifaceted national
communication initiative that supports
reduction of HIV incidence in the U.S.
through multiple, concurrent
communication and education
campaigns for a variety of audiences
including, the general public,
populations most affected by HIV and
health care providers. The campaigns
target consumers 18–64 years old and
include the following audiences: (1)
Men who have sex with men (MSM) of
all races; (2) Blacks/African Americans;
(3) Hispanics/Latinos; (4) Transgender
individuals; (5) HIV-positive
individuals; and (6) national audience

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Respondents

Form name

Individuals (males and
females) aged 18–64.

Study screener ....................................................

2338

1

2/60

78

Exploratory—HIV Testing In-depth Interview
Guide.
Exploratory—HIV Prevention In-depth Interview
Guide.
Exploratory—HIV Communication and Awareness In-depth Interview Guide.
Exploratory—HIV Prevention with Positives Indepth Interview Guide.
Consumer Message Testing In-depth Interview
Guide.

74

1

1

74

74

1

1

74

74

1

1

74

74

1

1

74

68

1

1

68

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Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Respondents

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

Consumer Concept Testing In-depth Interview
Guide.
Consumer Materials Testing In-depth Interview
Guide.
Exploratory—HIV Testing Focus Group Interview Guide.
Exploratory—HIV Prevention Focus Group Interview Guide.
Exploratory—HIV Communication and Awareness Focus Group Interview Guide.
Exploratory—HIV Prevention with Positives
Focus Group Interview Guide.
Consumer Concept Testing Focus Group Interview Guide.
Consumer Message Testing Focus Group Interview Guide.
Consumer Materials Testing Focus Group Interview Guide.
HIV Testing Survey .............................................
HIV Prevention Survey ........................................
HIV Communication and Awareness Survey ......
HIV Prevention with Positives Survey .................
Intercept Interview Guide ....................................
..............................................................................

Jeffrey M. Zirger,
Health Scientist, Acting Chief, Information
Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for
Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2016–15646 Filed 6–30–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0500]

Early Clinical Trials With Live
Biotherapeutic Products: Chemistry,
Manufacturing, and Control
Information; Guidance for Industry;
Availability
AGENCY:

Food and Drug Administration,

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
document entitled ‘‘Early Clinical Trials
With Live Biotherapeutic Products:
Chemistry, Manufacturing, and Control
Information; Guidance for Industry.’’
The guidance document provides
investigational new drug application
(IND) sponsors with recommendations
regarding IND submissions for early
clinical trials with live biotherapeutic

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SUMMARY:

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68

68

1

1

68

74

1

2

148

74

1

2

148

74

1

2

148

74

1

2

148

68

1

2

136

68

1

2

136

68

1

2

136

250
250
250
250
700

1
1
1
1
1

15/60
15/60
15/60
15/60
20/60

63
63
63
63
233

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

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

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

2,063

Submit electronic comments in the
following way:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to http://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that

Frm 00025

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hours

1

products (LBPs) in the United States.
The guidance announced in this notice
updates the guidance of the same title
dated February 2012 (February 2012
guidance) by addressing when the label
on the commercially available
products(s) would be considered
adequate to satisfy the purpose of the
chemistry, manufacturing, and control
(CMC) information requirements.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:

PO 00000

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burden per
response
(in hours)

68

Electronic Submissions

HHS.
ACTION:

Number of
responses per
respondent

Number of
respondents

Form name

Sfmt 4703

identifies you in the body of your
comments, that information will be
posted on http://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–D–0500 for ‘‘Early Clinical Trials
With Live Biotherapeutic Products:
Chemistry, Manufacturing, and Control
Information; Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
http://www.regulations.gov or at the

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