Att 2 - 60 day FRN

55259

Federal Register / Vol. 78, No. 175 / Tuesday, September 10, 2013 / Notices
Background and Brief Description
CDC provides technical guidance to
the Department of Health and Human
Services (HHS) in coordination with the
Centers for Medicare & Medicaid
Services (CMS) and the Food and Drug
Administration (FDA) for the
implementation of the Clinical
Laboratory Improvement Amendments
(CLIA). The Clinical Laboratory
Improvement Amendments of 1988
(CLIA) directed the Secretary of Health
and Human Services to establish the
maximum number of cytology slides
that any individual may screen in a 24
hour period; to establish certain quality
assurance standards; to set personnel
standards; and to provide for periodic
proficiency testing of cytotechnologists
and pathologists involved in screening
and interpreting cytological
preparations.
The regulations implementing CLIA,
published in the Federal Register of
February 28, 1992, established that the
maximum number of slides examined
by an individual in each 24 hour period
was not to exceed 100 slides and could
not be examined in less than an eight
hour day. The regulation further
established that the technical supervisor
is required to evaluate the performance
of cytotechnologists at least every six
months and determine their individual

maximum daily workload limit. In 1992,
when the regulation was published, all
Pap slides were conventional ‘‘Pap
smears.’’ In a conventional Pap smear,
samples are smeared directly onto a
glass microscope slide after collection.
The cells are often obscured by blood or
the smear may be too thick and contain
contaminating artifacts. Today, almost
all Pap tests in the U.S. are collected
with a liquid-based method. Instead of
‘‘smearing’’ cervical cells directly onto a
glass microscope slide, the cells are sent
to the laboratory in a liquid preservative
and processed by an automated
processor. This processor disperses a
uniform thickness representative sample
on the slide that is free of obscuring
blood, mucus, and non-diagnostic
debris in a circle that covers less than
one half of the slide.
CLIA’s Federal Advisory Committee,
the Clinical Laboratory Improvement
Advisory Committee (CLIAC), has
discussed cytology workload on
numerous occasions from 1996 until
present. On August 29, 2011 the
American Society of Cytopathology’s
(ASC) Executive Board approved an
ASC task force recommendation that the
average laboratory cytotechnologist
productivity should not exceed 70
slides and that an individual’s screening
time should not exceed seven (7) hours
in a 24 hour period.

Each laboratory will receive an
advance request to participate in the
Image-Assisted Cytology Workload
Practices Survey from a DLSS contractor
that has been selected to collect the
survey data and conduct the time
measure study. Respondents will be
cytology supervisors from the 1,245
cytology laboratories in the Unites
States. Since a response to this survey
is voluntary we would expect an 80%
response rate or approximately 996
laboratories. Responses would be
submitted in written format. The
estimated burden per response is one
half hour. In addition, individual
cytotechnologists working in the
laboratory will be asked to complete the
Image-Assisted Cytology Workload
Assessment Survey. There are 6,064
cytotechnologists in the United States.
Response to this survey is voluntary, so
we would expect an 80% response rate
or approximately 4,581
cytotechnologists. Responses would be
submitted in written format. The
estimated burden per response is one
half hour. CDC requests OMB approval
to collect information for one year.
There are no costs to respondents
other than their time.
The total estimated annual burden
hours are 2,789.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Cytology Supervisor ........................................
Cytotechnologists ............................................

Image-Assisted Cytology Workload Practices
Image-Assisted Cytology Workload Assessment.

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. 2013–21911 Filed 9–9–13; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–13–0199]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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Number of
respondents

Type of respondents

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

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996
4,581

Number of
responses per
respondent
1
1

Average
burden per
response
(in hrs.)
30/60
30/60

instruments, call 404–639–7570 and
send comments to LeRoy Richardson,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an email to omb@
cdc.gov.
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; 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

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Federal Register / Vol. 78, No. 175 / Tuesday, September 10, 2013 / Notices

be received within 60 days of this
notice.
Proposed Project: Importation of
Etiologic Agents (42 CFR 71.54) (OMB
Control No. 0920–0199, exp. 1/31/
2014)—Revision—Office of Public
Health Preparedness and Response
(OPHPR), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Section 361 of the Public Health
Service Act (42 U.S.C. 264), as
amended, authorizes the Secretary of
Health and Human Services to make
and enforce such regulations as are
necessary to prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the States or possessions,
or from one State or possession into any
other State or possession. Part 71 of
Title 42, Code of Federal Regulations
(Foreign Quarantine) sets forth
provisions to prevent the introduction,
transmission, and spread of
communicable disease from foreign
countries into the United States.
Subpart F—Importations—contains
provisions for the importation of
infectious biological agents, infectious
substances, and vectors (42 CFR 71.54);
requiring persons that import these
materials to obtain a permit issued by
the CDC.

imported, and the level of risk given its
intended use; and a secondary contact
information for the permittee to provide
in case the permittee is unavailable.
These additional data requests will not
affect the burden hours.
The Application for Permit to Import
or Transport Live Bats form is used by
laboratory facilities such as those
operated by government agencies,
universities, research institutions, and
for educational, exhibition, or scientific
purposes to request a permit for the
importation, and any subsequent
distribution after importation, of live
bats. This form currently requests the
applicant and sender contact
information; a description and intended
use of bats to be imported; and facility
isolation and containment information.
CDC plans to revise this application to
request secondary contact information
for the permittee to provide in case the
permittee is unavailable. These
additional data requests will not affect
the burden hours.
Estimates of burden for the survey are
based on information obtained from the
CDC import permit database on the
number of permits issued on annual
basis since 2010. The total estimated
burden for the one-time data collection
is 545 hours.
There are no costs to respondents
except their time.

CDC requests Office of Management
and Budget approval to collect
information for three years using the
Application for Permit to Import
Biological Agents, Infectious Substances
and Vectors of Human Disease into the
United States and Application for a
Permit to Import or Transport Live Bats.
We are also requesting a title change to
read—Application for Permit to Import
Infectious Biological Agents into the
United States (42 CFR 71.54.
The Application for Permit to Import
Biological Agents, Infectious Substances
and Vectors of Human Disease into the
United States form is used by laboratory
facilities, such as those operated by
government agencies, universities, and
research institutions to request a permit
for the importation of biological agents,
infectious substances, or vectors of
human disease. This form currently
requests applicant and sender contact
information; description of material for
importation; facility isolation and
containment information; and personnel
qualifications. CDC plans to revise this
application to request information on
where the imported material will be
stored at the recipient facility and who
would be responsible for this location;
verification that the permittee has
implemented biosafety measures
commensurate with the hazard posed by
the infectious biological agent,
infectious substance, and/or vector to be

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Total burden
hours

Form name

Applicants Requesting to Import Biological Agents, Infectious Substances and Vectors.

1,625

1

20/60

542

Applicants Requesting to Import Live
Bats.

Application for Permit to Import Biological Agents, Infectious Substances and Vectors of Human
Disease into the United States.
Application for a Permit to Import
Live Bats.

10

1

20/60

3

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

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

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

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

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

545

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1064]

[FR Doc. 2013–21974 Filed 9–9–13; 8:45 am]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Application for
Participation in the Medical Device
Fellowship Program

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responses per
respondent

Type of respondent

AGENCY:

Food and Drug Administration,

HHS.
ACTION:

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The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the application for participation in the
Medical Device Fellowship Program.

SUMMARY:

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