Att B 60 Day FRN

Att B 60 Day FRN.pdf

CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility Testing

Att B 60 Day FRN

OMB: 0920-0600

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CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis and
Nontuberculous Mycobacteria Drug Susceptibility Testing
Attachment B
60-day Federal Register Notice

4148

Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices
Name

CAS

1. Trichloroethylene (UPDATE) ..
2. Tetrachloroethylene (UPDATE).
3. Hydrogen sulfide/Carbonyl
sulfide (UPDATE).
4. Glutaraldehyde (NEW) ...........
5. Parathion (NEW) ....................

79–01–6
127–18–4
7783–06–4
463–58–1
111–30–8
56–38–2

Clifton Road NE., Mail Stop F–57,
Atlanta, GA 30333, telephone 770–488–
3313.
Dated: January 11, 2013.
Ken Rose,
Director, Office of Policy Planning and
Evaluation, National Center for
Environmental Health.
[FR Doc. 2013–00991 Filed 1–17–13; 8:45 am]

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SUPPLEMENTARY INFORMATION:

The

Superfund Amendments and
Reauthorization Act of 1986 (SARA) (42
U.S.C. 9601 et seq.) amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund) (42
U.S.C. 9601 et seq.) by establishing
certain requirements for ATSDR and the
U.S. Environmental Protection Agency
(EPA) with regard to hazardous
substances that are most commonly
found at facilities on the CERCLA
National Priorities List (NPL). Among
these statutory requirements is a
mandate for the Administrator of
ATSDR to prepare toxicological profiles
for each substance included on the
Priority List of Hazardous Substances
(www.atsdr.cdc.gov/SPL). This list
names 275 hazardous substances that
pose the most significant potential
threat to human health as determined by
ATSDR and EPA. The availability of the
revised list of the 275 priority
substances was announced in the
Federal Register on November 3, 2011
(76 FR 68193). For prior versions of the
list of substances, see Federal Register
notices dated April 17, 1987 (52 FR
12866); October 20, 1988 (53 FR 41280);
October 26, 1989 (54 FR 43619); October
17, 1990 (55 FR 42067); October 17,
1991 (56 FR 52166); October 28, 1992
(57 FR 48801); February 28, 1994 (59 FR
9486); April 29, 1996 (61 FR 18744;
November 17, 1997 (62 FR 61332);
October 21, 1999 (64 FR 56792); October
25, 2001 (66 FR 54014); November 7,
2003 (68 FR 63098); December 7, 2005
(70FR 70284): and March 6, 2008 (73 FR
12178).
Notice of the availability of drafts of
these five toxicological profiles for
public review and comment will be
published in the Federal Register on or
about October 17, 2013, with notice of
a 90-day public comment period for
each profile, starting from the actual
release date. Following the close of the
comment period, chemical-specific
comments will be addressed, and,
where appropriate, changes will be
incorporated into each profile.
FOR FURTHER INFORMATION CONTACT:
Commander Jessilynn B. Taylor,
Division of Toxicology and Human
Health Sciences, Agency for Toxic
Substances and Disease Registry, 1600

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16:52 Jan 17, 2013

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BILLING CODE P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–0600]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
instruments, call 404–639–7570 or send
comments to Ron Otten, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email to [email protected].
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
be received within 60 days of this
notice.
Proposed Project
CDC Model Performance Evaluation
Program (MPEP) for Mycobacterium
tuberculosis and Nontuberculous
Mycobacteria Drug Susceptibility
Testing OMB #0920–0600 (exp. 5/31/
2013),—Revision—National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).

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Background and Brief Description
As part of the continuing effort to
support domestic public health
objectives for treatment of tuberculosis
(TB), prevention of multi-drug
resistance, and surveillance programs,
CDC is requesting approval from the
Office of Management and Budget to
continue data collection from
participants in the Model Performance
Evaluation Program for Mycobacterium
tuberculosis and Non-tuberculous
Mycobacterium Drug Susceptibility
Testing. This revision request includes
(a) Changing the title of the data
collection to ‘‘CDC Model Performance
Evaluation (MPEP) for Mycobacterium
tuberculosis Drug Susceptibility
Testing’’ to reflect that nontuberculous
mycobacteria are no longer included in
the test package; (b) replacement of
Laboratory Enrollment Form with a
Participant Biosafety Compliance Letter
of Agreement; (c) revision of the Preshipment Email; (d) addition of
Instructions to Participants Letter; (e)
revision of the MPEP M. tuberculosis
Results Worksheet; (f) entering survey
results online using a modified data
collection instrument; (g) modification
of Reminder Email; (h) modification of
Reminder Telephone Script; and (i)
modification of the Aggregate Report
Letter.
While the overall number of cases of
TB in the U.S. has decreased, rates still
remain high among foreign-born
persons, prisoners, homeless
populations, and individuals infected
with HIV in major metropolitan areas.
To reach the goal of eliminating TB, the
Model Performance Evaluation Program
for Mycobacterium tuberculosis and
Non-tuberculous Mycobacterium Drug
Susceptibility Testing is used to monitor
and evaluate performance and practices
among national laboratories performing
M. tuberculosis susceptibility testing.
Participation in this program is one way
laboratories can ensure high-quality
laboratory testing, resulting in accurate
and reliable testing results.
By providing an evaluation program
to assess the ability of the laboratories
to test for drug resistant M. tuberculosis
strains, laboratories also have a selfassessment tool to aid in optimizing
their skills in susceptibility testing. The
information obtained from the
laboratories on susceptibility practices
and procedures is used to establish
variables related to good performance,
assessing training needs, and aid with
the development of practice standards.
Participants in this program include
domestic clinical and public health
laboratories. Data collection from
laboratory participants occurs twice per

E:\FR\FM\18JAN1.SGM

18JAN1

4149

Federal Register / Vol. 78, No. 13 / Friday, January 18, 2013 / Notices
year. The data collected in this program
will include the susceptibility test
results of primary and secondary drugs,
drug concentrations, and test methods
performed by laboratories on a set of

performance evaluation (PE) samples.
The PE samples are sent to participants
twice a year. Participants also report
demographic data such as laboratory

type and the number of tests performed
annually.
There is no cost to respondents to
participate other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Domestic Laboratory

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

Number of
respondents

Form name

Total burden
hours

93

2

5/60

16

93

2

30/60

93

93

2

15/60

47

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

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

0

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

156

[FR Doc. 2013–00988 Filed 1–17–13; 8:45 am]
BILLING CODE 4163–18–P

Proposed Project
Restriction on Interstate Travel of
Persons (OMB Control No. 0920–0488,
Exp. 3/31/2013)—Revision—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–13–0488]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to [email protected]. Send written
comments to 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.

The Centers for Disease Control and
Prevention is requesting OMB approval
for a revision of the information
collection, ‘‘Restriction on Interstate
Travel of Persons’’ (OMB Control No.
0920–0488).
This information collection request is
scheduled to expire on March 31, 2013.
CDC is authorized to collect this
information under 42 CFR 70.5 (Certain
communicable diseases; special
requirements). This regulation requires
that any person who is in the
communicable period for cholera,
plague, smallpox, typhus, or yellow
fever or having been exposed to any
such disease is in the incubation period
thereof, to apply for and receive a
permit from the Surgeon General or his
authorized representative in order to
travel from one State or possession to
another.
CDC is requesting changes to the
forms used within this information

Form name

Traveler ............................................

42 CFR 70.3 Application to the State of destination
for a permit.
42 CFR 70.3 Copy of material submitted by applicant and permit issued by State health authority.
42 CFR 70.3 Copy of material submitted by applicant and permit issued by State health authority.

State health authority .......................

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collection. The changes involve splitting
the current form into two separate forms
based on the type of respondent: an ill
traveler, or the master of a vessel or
conveyance engaged in interstate travel.
CDC is also adding the option of
electronic reporting of illness.
Control of disease transmission
within the States is considered to be the
province of state and local health
authorities, with Federal assistance
being sought by those authorities on a
cooperative basis without application of
Federal regulations. The regulations in
42 Part 70 were developed to facilitate
Federal action in the event of large
outbreaks requiring a coordinated effort
involving several states, or in the event
of inadequate local control. While it is
not known whether, or to what extent
situations may arise in which these
regulations would be invoked,
contingency planning for domestic
emergency preparedness is now
commonplace. Should these situations
arise, CDC will use the reporting and
recordkeeping requirements contained
in the regulations to carry out
quarantine responsibilities as required
by law. The total number of burden
hours requested for this collection is
3,701.
There is no cost to respondents other
than their time.
Number of
responses per
respondent

Number of
respondents

Type of respondent

Attending physician ..........................
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Average
burden per
response
(in hours)

Participant Biosafety Compliance Letter of Agreement.
MPEP Mycobacterium tuberculosis Results Worksheet.
Online Survey Instrument ........................................

Dated: January 14, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.

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Number of
responses per
respondent

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E:\FR\FM\18JAN1.SGM

Average
burden per
response
(in hours)

2,000

1

15/60

2,000

1

15/60

8

250

6/60

18JAN1


File Typeapplication/pdf
AuthorYakrus, Mitchell (CDC/OID/NCHHSTP)
File Modified2013-01-25
File Created2013-01-25

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