60 Day FRN - published

Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
provider in the United States who
intends to administer one of these
covered vaccines is required to provide
copies of the relevant vaccine
information materials prior to
administration of any of these vaccines.
Since then, the following vaccines have
been added to the National Vaccine
Injury Compensation Program, requiring
use of vaccine information materials for
them as well: Hepatitis B, Haemophilus
influenzae type b (Hib), varicella
(chickenpox), pneumococcal conjugate,
rotavirus, hepatitis A, meningococcal,
human papillomavirus (HPV), and
seasonal influenza vaccines.
Instructions for use of the vaccine
information materials are found on the
CDC Web site at: http://www.cdc.gov/
vaccines/hcp/vis/index.html.
Revised Vaccine Information Materials
The pneumococcal conjugate vaccine
(PCV13) information materials
referenced in this notice were
developed in consultation with the
Advisory Commission on Childhood
Vaccines, the Food and Drug
Administration, and parent and
healthcare provider organizations.
Following consultation and review of
comments submitted, the vaccine
information materials covering
pneumococcal conjugate vaccine
(PCV13) have been finalized and are
available to download from http://www.
cdc.gov/vaccines/hcp/vis/index.html or
http://www.regulations.gov (see Docket
Number CDC–2015–0014). The Vaccine
Information Statement (VIS) is
‘‘Pneumococcal Conjugate Vaccine
(PCV13): What You Need to Know,’’
publication date November 5, 2015.
With publication of this notice, as of
March 1, 2016, all health care providers
will be required to provide copies of
these updated pneumococcal conjugate
vaccine (PCV13) information materials
prior to immunization in conformance
with CDC’s November 5, 2015
Instructions for the Use of Vaccine
Information Statements.
Dated: December 16, 2015.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
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[FR Doc. 2015–31989 Filed 12–18–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0841; Docket No. CDC–2015–
0115]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 the Management
Information System for Comprehensive
Cancer Control Programs data
collection. CDC uses the electronic MIS
to collect information about cancer
prevention and control activities
conducted by states, territories, and
tribal organizations.
DATES: Written comments must be
received on or before February 19, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0115 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.
SUMMARY:

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.

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

FOR FURTHER INFORMATION CONTACT:

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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
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
Management Information System for
Comprehensive Cancer Control
Programs (OMB No. 0920–0841, exp. 3/
31/2016)—Revision—National Center
for Chronic Disease Prevention and

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Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices

Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
From 2007–2012, the Centers for
Disease Control and Prevention (CDC)
provided funding to all 50 states, the
District of Columbia, seven tribes/tribal
organizations, and seven territories/U.S.
Pacific Island Jurisdictions through the
National Cancer Prevention and Control
Program (CDC Funding Opportunity
Announcement [FOA] DP07–703). New
five-year cooperative agreements were
established in June 2012 under FOA
DP12–1205 (‘‘Cancer Prevention and
Control Program for State, Territorial
and Tribal Organizations’’). From 2012–
2015, a subset of 13 awardees received
additional funding for demonstration
programs to advance cancer control
using policy, systems, and
environmental change strategies.
Since 2010, cancer prevention and
control (CPC) awardees have used an
electronic management information
system (MIS) to submit semi-annual
progress reports to CDC (‘‘Management
Information System for Comprehensive
Cancer Control Programs,’’ OMB No.
0920–0841, exp. 3/31/2016). The
progress reports satisfy federal reporting
requirements and allow CDC to provide
targeted technical assistance to
awardees while monitoring their
activities and progress. The MIS also
provides CDC with the capacity to
respond in a timely manner to requests
for information from the Department of
Health and Human Services (HHS),
Congress, and other sources.

annualized, one-time allocation of two
hours response per response for initial
population of the MIS with information
that is specific to the new FOA. Due to
annualization, this activity is
represented in the table as 22 awardees
instead of 65 awardees. CDC is
considering a change in the frequency of
progress reporting, effective with the
new FOA. Routine progress reporting is
likely to occur once per year instead of
twice per year.
OMB approval will be requested for
three years. The total estimated
annualized burden for this reporting
period will decrease due to a reduction
in the estimated burden per response for
semi-annual reporting; a reduction in
the estimated burden per response for
populating the MIS with information
specific to the new FOA; and
discontinuation of semi-annual
reporting for demonstration program
activities.
Awardees are required to submit the
requested information to CDC as a
condition of funding. CDC will use the
information submitted by awardees to
identify training and technical
assistance needs, monitor compliance
with cooperative agreement
requirements, evaluate progress made in
achieving program-specific goals, and
obtain information needed to respond to
Congressional and other inquiries
regarding program activities and
effectiveness. All information will be
collected electronically. There are no
costs to respondents other than their
time.

CDC plans to request a revision of the
current MIS-based reporting system.
Minor modifications will be made to
standardize and streamline data entry;
for example, the open-ended text boxes
previously used to develop objectives
will be replaced with a drop-down
menu of evidence-based indicators. The
modifications will also make MIS
entries and output more user-friendly
for CDC staff who use the MIS to
monitor and evaluate specific program
outcomes. The search function will also
be modified to search for these
indicators.
All 65 DP12–1205 cancer prevention
and control awardees will continue to
submit semi-annual reports to CDC
through the end of the cooperative
agreement period. These reports include
information about personnel, resources,
finances, planning, action plans, and
progress. Information will be submitted
by the program director for the state,
territory, or tribal cancer control
program. Awardees will be responsible
for verifying their current information
and entering new objectives and
progress. To minimize respondent
burden, information that has not
changed does not need to be re-entered
into the MIS. The estimated burden for
ongoing system maintenance and semiannual reporting is being reduced from
three hours per response to two hours
per response.
CDC anticipates that DP12–1205 will
be succeeded in 2017 by a new FOA
based on similar objectives and a
comparable monitoring and evaluation
plan. The burden table includes an

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Avg. burden
per response
(in hrs.)

Total burden
(in hrs.)

Form name

Program Director for State-, Tribal-,
or Territorial-based Cancer Prevention and Control Program.

Data Elements for All CPC Programs: Semi-annual Reporting.

65

2

2

260

Data Elements for All CPC Programs: Initial MIS Population for
New FOA.

22

1

2

44

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

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

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

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

304

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

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Number of
respondents

Type of respondents

Leroy A. 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.
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