Appendix C 60 Day FRN

NIOSH Prevent Be Appendix C 60 day FRN.pdf

Long-Term Efficacy of a Program to Prevent Beryllium Disease

Appendix C 60 Day FRN

OMB: 0920-0771

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Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices

Dated: April 23, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–8073 Filed 4–26–07; 8:45 am]

National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).

BILLING CODE 4163–18–P

Beryllium is a lightweight metal with
many applications. Exposed workers
may be found in the primary
production, nuclear power and
weapons, aerospace, scrap metal
reclamation, specialty ceramics, and
electronics industries, among others.
The size of the USA workforce at risk
of chronic beryllium disease (CBD),
from either current or past work-related
exposure to the metal, may be as high
as one million. Demand for beryllium is
growing worldwide, which means that
increasing numbers of workers are likely
to be exposed.
Exposure to beryllium can lead to
sensitization and cause an immunologic
granulomatous lung disease.
Sensitization is a cell-mediated allergictype response that may be detected in
the peripheral blood with the beryllium
lymphocyte proliferation test (BeLPT),
which is used by the industry as a
surveillance tool. Workers found to be
sensitized may be clinically evaluated
for CBD with tests including
bronchoalveolar lavage and
transbronchial biopsy. Cross-sectional
studies in various beryllium workplace
populations have identified
sensitization in the range of less than
1% to 14% of workers. The proportion
of sensitized workers who have
beryllium disease at initial clinical
evaluation has varied from 10 to 100%
in different workplaces. Sensitized
workers not initially diagnosed with
CBD are often diagnosed with the
disease upon follow-up, but whether all
sensitized workers will eventually
develop beryllium disease is unknown.
Industry screening programs have
enabled the identification of CBD in
persons without apparent symptoms,
often early in disease progression (often
referred to as ‘‘subclinical disease’’).
Progression from sensitization to
subclinical disease to clinical
impairment, while difficult to predict
for any one individual, is not
uncommon.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–07–07AY]

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 404–639–5960 and
send comments to Joan Karr, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail 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
Long-Term Efficacy of a Program to
Prevent Beryllium Disease—New—

Currently, there are no preventive
programs that have been demonstrated
to have long-term effectiveness in
preventing beryllium sensitization and
CBD among beryllium-exposed workers.
In the United States, recent short-term
evidence (i.e., average work tenure 16
months, maximum four years) at one
facility suggests that the comprehensive
preventive program that was
implemented by company management
beginning in 2000 has successfully
reduced the incidence of beryllium
sensitization, as defined by the
occurrence of confirmed abnormal
BeLPTs. However, the follow-up has
thus far been limited to current workers,
the duration has been too short to
document a reduced incidence of CBD,
and it is possible that sensitization has
been delayed, rather than prevented.
Evaluation of this program’s
effectiveness would therefore be more
complete by including individuals who
have left employment and documenting
whether: (1) The program was effective
at two other facilities at which it was
implemented, (2) the program prevented
beryllium sensitization over a longer
period of time (i.e., up to eight years);
and (3) the program prevented CBD,
which generally takes longer to develop.

Background and Brief Description

Study Design
This proposed study is designed to
evaluate the effectiveness of a
comprehensive preventive program at
three beryllium plants. Eligible workers
for this survey include those hired
between implementation of a
comprehensive program (2000–01) and
December 31, 2008, including any
already known to be sensitized. NIOSH
will offer all eligible current and former
workers the BeLPT to identify
sensitization and administer a work and
medical history questionnaire.
There are no costs to former worker
respondents except their time to
participate in the interview. Current
workers will participate during work
hours, and will thus be compensated for
their time by their employer. Former
workers will participate during their
own time.

ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents

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Respondents
Current Workers ..............................................................................................
Former Workers ...............................................................................................

239
340

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

579

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Number of
responses/respondent

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1
1

Avg. burden/
response
(in hours)
45/60
45/60

Total burden
(in hours)
179
255
434

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Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices
Dated: April 23, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–8075 Filed 4–26–07; 8:45 am]
BILLING CODE 4163–18–P

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request

Centers for Disease Control and
Prevention

In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned SEP:

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Time and Date: 1 p.m.–4 p.m., June 4, 2007
(Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of scientific merit of grant
applications received in response to RFA
DD07–008, ‘‘Optimal Resources and Care for
Children with Craniofacial Malformations,’’
and RFA DD07–009, ‘‘Public Health Research
Grants on Orofacial Clefts and
Craniosynostosis,’’ RFA DD07–009.
Contact Person for More Information:
Maurine Goodman, MA, MPH, Scientific
Review Administrator, Centers for Disease
Control and Prevention, 1600 Clifton Road,
NE., Mailstop D72, Atlanta, GA 30333,
Telephone 404.639.4737.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 20, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–8074 Filed 4–26–07; 8:45 am]
BILLING CODE 4163–18–P

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Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid
Managed Care Regulations for 42 CFR
438.6, 438.8, 438.10, 438.12, 438.50,
438.56, 438.102, 438.114, 438.202,
438.204, 438.206, 438.207, 438.240,
438.242, 438.402, 438.404, 438.406,
438.408, 438.410, 438.414, 438.416,
438.604, 437.710, 438.722, 438.724, and
438.810; Use: These information
collection requirements implement
regulations that allow States greater
flexibility to implement mandatory
managed care program, implement new
beneficiary protections, and eliminate
certain requirements viewed by State
agencies as impediments to the growth
of managed care programs. Information
collected includes information about
managed care programs, grievances and
appeals, enrollment broker contracts,
and managed care organizational
capacity to provide health care services.
Form Number: CMS–10108 (OMB#:
0938–0920); Frequency: Reporting:
Occasionally; Affected Public: State,
Local, or Tribal Government; Number of
Respondents: 39,114,558; Total Annual

AGENCY:

Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Optimal
Resources and Care for Children With
Craniofacial Malformations, Request
for Applications (RFA) DD07–008 and
Public Health Research Grants on
Orofacial Clefts and Craniosynostosis,
RFA DD07–009

15:18 Apr 26, 2007

Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10108, CMS–
10219, CMS–10097]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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HUMAN SERVICES

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Responses: 4,640,344; Total Annual
Hours: 3,930,093.5.
2. Type of Information Collection
Request: New collection; Title of
Information Collection: Health Plan
Employer Data and Information Set
(HEDIS); Use: The Centers for
Medicare & Medicaid Services (CMS)
collects quality performance measures
in order to hold the Medicare managed
care industry accountable for the care
being delivered, to enable quality
improvement, and to provide quality
information to Medicare beneficiaries in
order to promote an informed choice. It
is critical to CMS’ mission that we
collect and disseminate information that
will help beneficiaries choose among
health plans, contribute to improved
quality of care through identification of
improvement opportunities, and assist
CMS in carrying out its oversight and
purchasing responsibilities.
In December 1997, OMB approved the
request from CMS for the information
collections under HEDIS and assigned
the agency form number CMS–R–200.
The collections approved under that
request included the HEDIS collection
(following the technical specifications
contained in Volume 2, published by
the National Committee for Quality
Assurance (NCQA); the Health of
Seniors/Health Outcomes Survey (HOS);
and the Medicare CAHPS survey.
Since that approval there has been a
change in the statutory authority as a
result of the Balanced Budget Act of
1997. During the latter part of 2000,
CMS instituted several policy changes
regarding this collection which reduced
burden substantially on the part of the
managed care organizations and the
process for finalizing and publishing
that policy delayed the request for OMB
approval. In addition, the renewal of
OMB authority for the Medicare CAHPS
survey was completed as a separate
request. The HOS renewal was also
submitted separately. This request is
solely for the approval of the HEDIS
collection, which is now a stand alone
collection. Form Number: CMS–10219
(OMB#: 0938–NEW); Frequency: Yearly;
Affected Public: Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 705; Total
Annual Responses: 705; Total Annual
Hours: 33,840.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Contractor Provider Satisfaction Survey
(MCPSS); Form No.: CMS–10097
(OMB#: 0938–0915); Use: The Centers
for Medicare & Medicaid Services will
obtain feedback from Medicare
providers via a survey about

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File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2007-05-02
File Created2007-05-02

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