Agency Forms Undergoing Paperwork Reduction Act Review, 33195-33196 [2014-13396]
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33195
Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
General population ..........................................
CMEP–WILLOW grantees ..............................
General population ..........................................
CMEP–WILLOW grantees ..............................
90-day Follow-up Survey ...............................
90-day SDN Submission ................................
180-day Follow-up Survey .............................
180-day SDN Submission ..............................
Leroy Richardson,
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. 2014–13397 Filed 6–9–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–14–0895]
emcdonald on DSK67QTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
VerDate Mar<15>2010
16:55 Jun 09, 2014
Jkt 232001
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Community-based Organization (CBO)
Monitoring and Evaluation Project
(CMEP) of RESPECT (CMEP–RESPECT)
(OMB No. 0920–0895, expires
8/31/2014)—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 began formally partnering with
CBOs in the late 1980s to expand the
reach of HIV prevention efforts. CBOs
were, and continue to be, recognized as
important partners in HIV prevention
because of their history and credibility
with target populations and their access
to groups that may not be easily
reached. Over time, CDC’s program for
HIV prevention by CBOs has grown in
size, scope, and complexity to respond
to changes in the epidemic, including
the diffusion and implementation of
Effective Behavioral Interventions (EBIs)
for HIV prevention.
CDC’s EBIs have been shown to be
effective under controlled research
environments, but there is limited data
on intervention implementation and
client outcomes in real-world settings
(as implemented by CDC-funded CBOs).
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
320
4
320
4
Number of
responses per
respondent
1
12
1
12
Avg. burden
per response
(in hrs.)
18/60
5/60
18/60
5/60
The purpose of CMEP is to improve the
performance of CDC-funded CBOs
delivering particular individual- or
group-level behavioral interventions.
This is done by monitoring changes in
clients’ self-reported HIV transmission
risk behaviors after participating in the
intervention.
CDC funded four (4) CBOs to
participate in CMEP-Respect for five (5)
years (September 2010–August 2015).
CDC funded CMEP-Respect for five (5)
years (September 2010–August 2015).
From April 1, 2012 through April 30,
2014 baseline surveys were conducted
with an estimated 871 participants; 90–
day follow up surveys were completed
with 576 participants, and 180-day
follow up surveys were completed with
484 participants.
CDC is requesting additional time to
complete follow up surveys at 90- and
180-days for participants completing the
intervention on or before 8/31/2014.
Following their participation in the
Respect intervention, participants will
complete an 18 minute, selfadministered, computer based interview
at two follow-up time points (90- and
180-days following the Respect
intervention) to assess their HIV-related
attitudes and behavioral risks. CBOs
will be expected to retain 80% of these
participants at both follow-up
interviews. CBO agency staff will
submit data files to CDC monthly. It is
estimated it will take 5 minutes to
upload to the CDC’s Secure Data
Network (SDN).
Throughout the project, funded CBOs
will be responsible for managing the
daily procedures of CMEP-Respect to
ensure that all required activities are
performed, all deadlines are met, and
quality assurance plans, policies and
procedures are upheld. CBOs will be
responsible for participating in all CDCsponsored grantee meetings related to
CMEP-Respect. The total estimated
annual burden hours are 200.
E:\FR\FM\10JNN1.SGM
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33196
Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
General population ..........................................
CMEP-Respect grantees ................................
General Population .........................................
CMEP-Respect grantees ................................
90-Day Follow-Up Survey ..............................
90-Day SDN Submission ...............................
180-day Follow-up Survey .............................
180-Day SDN Submission .............................
Leroy Richardson,
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.
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2014–13396 Filed 6–9–14; 8:45 am]
BILLING CODE 4163–18–P
Guidance for Industry and Food and
Drug Administration Staff on Section
905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products—(OMB Control Number 0910–
0673)—(Extension)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1558]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence for Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 10,
2014.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0673. Also
include the FDA docket number found
in brackets in the heading of this
document.
emcdonald on DSK67QTVN1PROD with NOTICES
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
FOR FURTHER INFORMATION CONTACT:
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On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a new chapter
granting FDA authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 905(j) of the FD&C Act (21
U.S.C. 387e(j)) authorizes FDA to
establish the form for the submission of
information related to substantial
equivalence. In a level 1 guidance
document issued under the Good
Guidances Practices regulation (21 CFR
10.115), FDA provides
recommendations intended to assist
persons submitting reports under
section 905(j) of the FD&C Act and
explains, among other things, FDA’s
interpretation of the statutory sections
related to substantial equivalence.
In the Federal Register of December
27, 2013 (78 FR 78974), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Six comment submissions
were received, some of which included
multiple comments. Two of the six
comment submissions were in favor of
FDA’s regulation of tobacco products.
Three comment submissions were
considered to contain PRA-related
comments and three comment
submission were not considered to
contain PRA-related comments. The
three comment submissions not
considered to contain PRA-related
PO 00000
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Fmt 4703
Sfmt 4703
320
4
320
4
Number of
responses per
respondent
1
12
1
12
Average
burden per
response
(in hrs)
18/60
5/60
18/60
5/60
comments are beyond the scope of this
Federal Register notice.
(Comment 1) One commenter
supported FDA in its mission to regulate
tobacco products for the benefit of
public health and safety and indicated
that language in the guidance be
strengthened to assist in FDA reviews.
The commenter also suggested that the
respondents provide additional
information to minimize future Freedom
of Information Act requests.
(Response 1) FDA agrees that the
request in this collection of information
is necessary to fulfill the requirements
of the FD&C Act. The type of data for
a given new product may vary
depending on whether the
characteristics of the product are the
same or different from a predicate
tobacco product, and the information is
needed to allow FDA to make informed
decisions when reviewing a substantial
equivalence application.
(Comment 2) Several commenters
indicated that FDA has improperly
implemented the substantial
equivalence provisions of the statute
(the FD&C Act, as amended by the
Family Smoking Prevention and
Tobacco Control Act (FSPTCA)), and
maintain that FDA is asking for reports
that are neither authorized nor relevant
to a substantial equivalence
determination.
(Response 2) FDA disagrees with the
comment. The information FDA is
requesting is related to new products
using the substantial equivalence
pathway to assist FDA in making a
determination of whether a product is
substantially equivalent.
(Comment 3) Several commenters
asserted that FDA was not asking for
enough information, while other
commenters asserted that FDA was
asking for too much information.
(Response 3) FDA believes that the
collection of information is necessary
and the burden estimates are
appropriate and reflect the amount of
time a respondent would need to
prepare a substantial equivalence
submission.
(Comment 4) One commenter noted
that under FDA’s interpretation, every
new, including modified, product
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]]>Agencies
[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33195-33196]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13396]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-0895]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
Community-based Organization (CBO) Monitoring and Evaluation
Project (CMEP) of RESPECT (CMEP-RESPECT) (OMB No. 0920-0895, expires 8/
31/2014)--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 began formally partnering with CBOs in the late 1980s to expand
the reach of HIV prevention efforts. CBOs were, and continue to be,
recognized as important partners in HIV prevention because of their
history and credibility with target populations and their access to
groups that may not be easily reached. Over time, CDC's program for HIV
prevention by CBOs has grown in size, scope, and complexity to respond
to changes in the epidemic, including the diffusion and implementation
of Effective Behavioral Interventions (EBIs) for HIV prevention.
CDC's EBIs have been shown to be effective under controlled
research environments, but there is limited data on intervention
implementation and client outcomes in real-world settings (as
implemented by CDC-funded CBOs). The purpose of CMEP is to improve the
performance of CDC-funded CBOs delivering particular individual- or
group-level behavioral interventions. This is done by monitoring
changes in clients' self-reported HIV transmission risk behaviors after
participating in the intervention.
CDC funded four (4) CBOs to participate in CMEP-Respect for five
(5) years (September 2010-August 2015). CDC funded CMEP-Respect for
five (5) years (September 2010-August 2015). From April 1, 2012 through
April 30, 2014 baseline surveys were conducted with an estimated 871
participants; 90-day follow up surveys were completed with 576
participants, and 180-day follow up surveys were completed with 484
participants.
CDC is requesting additional time to complete follow up surveys at
90- and 180-days for participants completing the intervention on or
before 8/31/2014. Following their participation in the Respect
intervention, participants will complete an 18 minute, self-
administered, computer based interview at two follow-up time points
(90- and 180-days following the Respect intervention) to assess their
HIV-related attitudes and behavioral risks. CBOs will be expected to
retain 80% of these participants at both follow-up interviews. CBO
agency staff will submit data files to CDC monthly. It is estimated it
will take 5 minutes to upload to the CDC's Secure Data Network (SDN).
Throughout the project, funded CBOs will be responsible for
managing the daily procedures of CMEP-Respect to ensure that all
required activities are performed, all deadlines are met, and quality
assurance plans, policies and procedures are upheld. CBOs will be
responsible for participating in all CDC-sponsored grantee meetings
related to CMEP-Respect. The total estimated annual burden hours are
200.
[[Page 33196]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs)
----------------------------------------------------------------------------------------------------------------
General population.................... 90-Day Follow-Up Survey. 320 1 18/60
CMEP-Respect grantees................. 90-Day SDN Submission... 4 12 5/60
General Population.................... 180-day Follow-up Survey 320 1 18/60
CMEP-Respect grantees................. 180-Day SDN Submission.. 4 12 5/60
----------------------------------------------------------------------------------------------------------------
Leroy Richardson,
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. 2014-13396 Filed 6-9-14; 8:45 am]
BILLING CODE 4163-18-P
