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Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices
burden per response for completing the
mail-in questionnaire is 15 minutes. In
addition, respondents will be asked to
provide contact information for all
health care providers they have seen in
the five years prior to their diagnosis
with cervical cancer, and to complete a
Health Insurance Portability and
Accountability Act (HIPAA) Release
form that allows study staff to access the
medical records maintained by these
providers. For each CICC participant,
the estimated burden per response for
the health care provider list and HIPAA
Release form is five minutes.
Third, medical chart abstractors will
collect information from the health care
providers who provided relevant
services to study participants in the five
years prior to their diagnosis with
invasive cervical cancer. The medical
record abstraction process does not
entail burden to study participants, or to
the medical chart abstractors who will
review the medical charts on a fee-for-

abstraction process is expected to
require follow-up with 1–5 (average of
3) health care providers (N = 2004).
Findings from this study will be used
to inform interventions targeted to reach
women who are never or rarely screened
for cervical cancer. Study findings will
be disseminated through reports,
presentations, and publications. Results
will also be used by participating sites,
CDC, and other federal agencies to
improve services provided to women at
risk of invasive cervical cancer.
OMB approval is requested for two
years. All personal identifier
information will be maintained by the
cancer registries where it is stored as
part of the standard registry data
repository. No identifiable information
will be collected by CDC or CDC’s main
contractor. Participation is voluntary
and there are no costs to respondents
other than their time.

service basis. The medical record
abstraction process does entail
additional recordkeeping burden to
office assistants for health care
providers, who are required to maintain
records of disclosures of medical
information, e.g., the HIPAA Release
Form for the CICC study. The estimated
burden for support activities associated
with each medical record abstraction is
five minutes.
CDC has identified three states as
potential study sites. Based on
preliminary data from their state cancer
registries, a total of approximately 1,670
eligible cervical cancer survivors are
eligible for participation. CDC estimates
a survey response rate of 50% of across
the entire sample (N = 835) followed by
an 80% acceptance of medical chart
verification (N = 668). These estimates
yield approximately 668 women with
complete data for both surveys and
chart verification. For each CICC
participant, the medical chart

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Invasive cervical cancer survivors ....

Case Investigation of Cervical Cancer Study Survey.
HIPAA Release and Listing of medical providers in last 5 years.
Support for medical record abstraction.

Health care office assistant ..............
Total ...........................................

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

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.
[FR Doc. 2016–06706 Filed 3–23–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–16VB; Docket No. CDC–2016–
0032]
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Type of respondent

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

AGENCY:

ACTION:

Notice with comment period.

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1

15/60

105

314

1

5/60

28

1,002

1

5/60

84

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

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

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

217

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 a proposed information
collection request entitled ‘‘HIV
Knowledge, Beliefs, Attitudes, and
Practices of Providers in the Southeast
(K–BAP Study)’’. CDC is requesting a
three-year approval for new data
collection to identify areas of HIV
prevention knowledge and practice
strengths and deficits among primary
care providers, in order to target limited
HIV prevention resources to achieve the
greatest reduction in new HIV infections
and optimize HIV clinical care in
clinical settings. The target population
will be primary care providers
practicing in high-prevalence

Frm 00049

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Total burden
(in hours)

418

SUMMARY:

PO 00000

Average
burden per
response
(in hours)

Number of
responses per
respondent

Sfmt 4703

metropolitan statistical geographic areas
with large at-risk African American
populations.
Written comments must be
received on or before May 23, 2016.

DATES:

You may submit comments,
identified by Docket No. CDC–2016–
0032 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:

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Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices

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
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

asabaliauskas on DSK3SPTVN1PROD with NOTICES

FOR FURTHER INFORMATION CONTACT:

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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
HIV Knowledge, Beliefs, Attitudes,
and Practices of Providers in the
Southeast (K–BAP Study)—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Persons at high risk of HIV infection
have often had one or more contacts
with a health care provider within a
year of their diagnoses. These health
care encounters represent missed
opportunities to: (1) Review and discuss
sexual health and risk reduction, (2)
screen for HIV infection and other STDs,
(3) recognize and diagnose acute HIV
infection and offer immediate
antiretroviral therapy (ART) if
indicated, (4) discuss the prevention
benefit of treatment (with subsequent
referral or prescription) and reengagement in care, as appropriate, and
(5) provide PrEP and nPEP if not
infected and at high risk, consistent
with current HIV prevention guidelines
and recommendations.
Health care providers in highprevalence geographic areas could
substantially reduce new HIV infections
among the patient populations they
serve, as well as their communities.
Health care providers are a trusted
source of reliable information. They also
have the capacity to perform STD/HIV
testing and to prescribe medication with
appropriate clinical follow-up.
Review of the literature published
between January 2000 and June 2014
indicates we know little about
providers’ knowledge, beliefs, attitudes,
and practices (K–BAP) in at-risk
jurisdictions about HIV risk, HIV
diagnosis and antiretroviral drug
interventions in these domains,
especially primary care providers
serving high-risk patients in highprevalence communities. K–BAP Study
is an effort to assess providers’ K–BAP
using a cross sectional survey in the five
priority HIV prevention domains noted
above.

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This K–BAP Study aligns with
multiple goals and objectives of the
National HIV/AIDS Strategy (NHAS)
and CDC’s ‘‘winnable battles.’’
The project’s specific objectives are to
(1) Characterize knowledge, beliefs,
attitudes, and practices of providers in
five key HIV prevention domains in
high-HIV prevalence communities with
disproportionate numbers of blacks/
African Americans, and (2) Educate
providers about prevention
interventions related to these domains
based on survey-identified knowledge,
beliefs, attitudes, and practices of
providers’ deficits.
The respondent population of medical
providers will be pulled from the
Healthcare Data Solutions (HDS)
ProviderPRO and MidLevelPRO
databases. Respondents will be
recruited to participate in the survey
through a combination of emails and
phone calls. This strategy will consist of
four emails spaced one week apart
followed by phone calls to nonresponders. The emails will explain the
purpose of the survey, the availability of
continuing education (CE) credits, and
the $20 cash token of appreciation.
A large two-part internet-based survey
will be conducted among a
representative random sample of
providers in the selected six (6)
metropolitan statistical areas (MSAs)
with the highest HIV burden among the
African American population. Part one
of survey will be administered to
participants at the beginning of project.
The part-one survey findings will used
to identify providers’ knowledge,
beliefs, attitudes, and practices of
providers that might require additional
educational reinforcement. Based on
survey responses, providers will be
linked to continuing education (CE)
credit-eligible educational modules to
improve their educational deficits. The
educational modules are all web-based
using either video or case-based
methods of learning. The length of the
course range from 1–3 hours accounting
for 0.25—1.0 credit hours. Part two of
survey will be administered six months
later comprising of only the core
questions in part one of survey to assess
impact of CE modules on providers’
practices regarding HIV prevention and
treatment.
There are no costs to respondents
other than their time. The total annual
burden hours are 1,172.

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Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in Hours)

Number of
responses per
respondent

Total burden
(in hours)

Form name

Providers ...........................................

K–BAP Provider Baseline Screener
and Survey.
K–BAP Provider Follow-Up Screener and Survey.

1,827

1

29/60

883

914

1

19/60

289

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

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

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

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

1,172

Providers ...........................................
Total ...........................................

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.
[FR Doc. 2016–06707 Filed 3–23–16; 8:45 am]
BILLING CODE 4163–18–P

Food and Drug Administration
[Docket No. FDA–2015–N–3662]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
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 April 25,
2016.
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_
[email protected]. All
comments should be identified with the
OMB control number 0910–0584. Also
include the FDA docket number found
in brackets in the heading of this
document.

ADDRESSES:

FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver

FOR FURTHER INFORMATION CONTACT:

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17:44 Mar 23, 2016

Jkt 238001

Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.

SUPPLEMENTARY INFORMATION:

Guidance on Reagents for Detection of
Specific Novel Influenza A Viruses—21
CFR Part 866 OMB Control Number
0910–0584—Extension

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Type of respondent

In accordance with section 513 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360c), FDA
evaluated an application for an in vitro
diagnostic device for detection of
influenza subtype H5 (Asian lineage),
commonly known as avian flu. FDA
concluded that this device is properly
classified into class II in accordance
with section 513(a)(1)(B) of the FD&C
Act, because it is a device for which the
general controls by themselves are
insufficient to provide reasonable
assurance of the safety and effectiveness
of the device, but there is sufficient
information to establish special controls
to provide such assurance. The statute
permits FDA to establish as special
controls many different things,
including postmarket surveillance,
development and dissemination of
guidance recommendations, and ‘‘other
appropriate actions as the Secretary
deems necessary’’ (section 513(a)(1)(B)
of the FD&C Act). This information
collection is a measure that FDA
determined to be necessary to provide
reasonable assurance of safety and
effectiveness of reagents for detection of
specific novel influenza A viruses.
FDA issued an order classifying the
H5 (Asian lineage) diagnostic device
into class II on March 22, 2006 (71 FR
14377), establishing the special controls
necessary to provide reasonable
assurance of the safety and effectiveness
of that device and similar future
devices. The new classification was
codified in 21 CFR 866.3332, a
regulation that describes the new
classification for reagents for detection
of specific novel influenza A viruses

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and sets forth the special controls that
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation refers to the special controls
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
Reagents for Detection of Specific Novel
Influenza A Viruses,’’ which provides
recommendations for measures to help
provide a reasonable assurance of safety
and effectiveness for these reagents. The
guidance document recommends that
sponsors obtain and analyze postmarket
data to ensure the continued reliability
of their device in detecting the specific
novel influenza A virus that it is
intended to detect, particularly given
the propensity for influenza viruses to
mutate and the potential for changes in
disease prevalence over time. As
updated sequences for novel influenza
A viruses become available from the
World Health Organization, National
Institutes of Health, and other public
health entities, sponsors of reagents for
detection of specific novel influenza A
viruses will collect this information,
compare them with the primer/probe
sequences in their devices, and
incorporate the result of these analyses
into their quality management system,
as required by 21 CFR 820.100(a)(1).
These analyses will be evaluated against
the device design validation and risk
analysis required by 21 CFR 820.30(g) to
determine if any design changes may be
necessary.
FDA estimates that 10 respondents
will be affected annually. Each
respondent will collect this information
twice per year; each response is
estimated to take 15 hours. This results
in a total data collection burden of 300
hours.
The guidance also refers to previously
approved information collections found
in FDA regulations. The collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 807 subpart
E have been approved under OMB
control number 0910–0120; and the
collections of information in 21 CFR

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