Agency Forms Undergoing Paperwork Reduction Act Review, 9827-9828 [E6-2710]
Download as PDF
<![CDATA[
9827
Federal Register / Vol. 71, No. 38 / Monday, February 27, 2006 / Notices
Dated: February 21, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–2709 Filed 2–24–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–06–0463]
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 the CDC Reports Clearance
Officer at (404) 639–4766 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Longitudinal Surveillance for
Beryllium Disease Prevention—0920–
0463—Extension—National Institute for
Occupational Safety and Health
(NIOSH)—Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The mission of the National Institute
for Occupational Safety and Health
(NIOSH) is to promote safety and health
at work for all people through research
and prevention. The Occupational
Safety and Health Act, Public Law 91–
596 (section 20[a][1]) authorizes the
National Institute for Occupational
Safety and Health (NIOSH) to conduct
research to advance the health and
safety of workers. NIOSH is conducting
a study of beryllium workers. 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 U.S.
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.
CBD is a chronic granulomatous lung
disease mediated through an
immunologic mechanism in workers
who become sensitized to the metal.
Sensitization can be detected with a
blood test called the beryllium
lymphocyte proliferation test (BeLPT),
which is used by the industry as a
surveillance tool. Use of this test for
surveillance was first reported in 1989.
Sensitized workers, identified through
workplace surveillance programs,
undergo clinical diagnostic tests to
determine whether they have CBD.
Research has indicated certain genetic
determinants in the risk of CBD; followup studies will be invaluable for further
characterizing the genetic contribution
to sensitization and disease.
NIOSH is in a unique position to
accomplish this research for a number
of reasons: (a) It has a successful
collaboration with the leading
manufacturer of beryllium in the US.
This has allowed us to establish wellcharacterized worker cohorts within the
beryllium industry. (b) It is conducting
industrial hygiene research that should
significantly improve workplace-based
exposure assessment methods. This
research will allow characterization of
jobs and tasks by physicochemical
characteristics, leading to an estimation
of dose rather than mass concentrationbased exposure. (c) It has pioneered the
evaluation of the dermal exposure route
in the beryllium sensitization process.
(d) It has developed and improved
genetic research that will contribute to
the understanding of risk variability in
sensitization and disease, as well as
discerning the underlying mechanisms.
(e) NIOSH has the institutional stability
to continue longitudinal evaluations of
health outcomes in relation to exposure
and genetic risk factors.
NIOSH has been conducting this
survey of beryllium workers for three
years and this extension will allow for
completion of the data collection on
former workers. Workers are asked to
complete an interviewer administered
medical and work history questionnaire
and to give a blood sample. Without
medical and work history data on
former workers, NIOSH staff will be
unable to conduct the necessary
research to make recommendations for
preventing beryllium sensitization and
disease. Follow-up on this cohort will
provide invaluable information on the
natural history of disease, gene-gene,
and gene-environment interactions,
which can become the basis for
prevention policy at both company and
government levels.
There are no costs to the respondents
other than their time. The only change
to this previously approved project is a
decrease in the burden hours because
the proposed data collection is almost
complete. The total estimated
annualized burden hours are 50.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Former Workers ...........................................................................................................................
hsrobinson on PROD1PC70 with NOTICES
Respondents
100
1
30/60
VerDate Aug<31>2005
14:15 Feb 24, 2006
Jkt 208001
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
E:\FR\FM\27FEN1.SGM
27FEN1
9828
Federal Register / Vol. 71, No. 38 / Monday, February 27, 2006 / Notices
Dated: February 21, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–2710 Filed 2–24–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0443]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: 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 March 29,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Focus Groups as Used by the Food and
Drug Administration—(OMB Control
Number 0910–0497)—Extension
FDA will collect and use information
gathered through the focus group
vehicle. This information will be used
to develop programmatic proposals, and
as such, compliments other important
research findings to develop these
proposals. Focus groups do provide an
important role in gathering information
because they allow for a more in-depth
understanding of consumers’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies.
Also, information from these focus
groups will be used to develop policy
and redirect resources, when necessary,
to our constituents. If this information is
not collected, a vital link in information
gathering by FDA to develop policy and
programmatic proposals will be missed
causing further delays in policy and
program development.
In the Federal Register of November
25, 2005 (FR 70 71165), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. FDA received one comment,
however it was not related to the
information collection.
Annually, FDA projects about 28
focus group studies using 286 focus
groups lasting an average of 1.78 hours
each. FDA has allowed burden for
unplanned focus groups to be
completed so as not to restrict the
agency’s ability to gather information on
public sentiment for its proposals in its
regulatory as well as other programs. To
arrive at each center’s estimated burden
we multiplied the number of focus
groups per study by the number of
participants per group. (e.g., Center for
Biologics Evaluation and Research
(CBER): 5x9=45). We multiplied that
total by the hours of duration for each
group to arrive at the total burden hours.
(e.g., CBER: 45x1.58=71.1).
The total annual estimated burden
imposed by this collection of
information is 4,252 hours annually.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
FDA Center
No. of
Focus
Groups per
Study
Subject
No. of
Focus
Groups
Sessions
Conducted
Annually
No. of
Participants
per Group
Hours of
Duration for
Each Group
(Includes
Screening)
Total Hours
May use focus groups when appropriate
1
5
9
1.58
71
Center for Drug Evaluation and
Research
Varies (e.g., direct-to-consumer
Rx drug promotion, physician
labeling of Rx drugs, medication guides, over-the-counter
drug labeling, risk communication)
10
200
9
1.58
2,844
Center for Devices and Radiological Health
Varies (e.g., FDA Seal of Approval, patient labeling, tampons, on-line sales of medical
products, latex gloves)
4
16
9
2.08
300
Center for Food Safety and Applied Nutrition
hsrobinson on PROD1PC70 with NOTICES
Center for Biologics Evaluation
and Research
Varies (e.g., food safety, nutrition,
dietary supplements, and consumer education)
8
40
9
1.58
569
Center for Veterinary Medicine
Varies (e.g., animal nutrition, supplements, labeling of animal
Rx)
5
25
9
2.08
468
VerDate Aug<31>2005
14:15 Feb 24, 2006
Jkt 208001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
E:\FR\FM\27FEN1.SGM
27FEN1
]]>Agencies
[Federal Register Volume 71, Number 38 (Monday, February 27, 2006)]
[Notices]
[Pages 9827-9828]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2710]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-06-0463]
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
the CDC Reports Clearance Officer at (404) 639-4766 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
Longitudinal Surveillance for Beryllium Disease Prevention--0920-
0463--Extension--National Institute for Occupational Safety and Health
(NIOSH)--Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The mission of the National Institute for Occupational Safety and
Health (NIOSH) is to promote safety and health at work for all people
through research and prevention. The Occupational Safety and Health
Act, Public Law 91-596 (section 20[a][1]) authorizes the National
Institute for Occupational Safety and Health (NIOSH) to conduct
research to advance the health and safety of workers. NIOSH is
conducting a study of beryllium workers. 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 U.S. 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.
CBD is a chronic granulomatous lung disease mediated through an
immunologic mechanism in workers who become sensitized to the metal.
Sensitization can be detected with a blood test called the beryllium
lymphocyte proliferation test (BeLPT), which is used by the industry as
a surveillance tool. Use of this test for surveillance was first
reported in 1989. Sensitized workers, identified through workplace
surveillance programs, undergo clinical diagnostic tests to determine
whether they have CBD. Research has indicated certain genetic
determinants in the risk of CBD; follow-up studies will be invaluable
for further characterizing the genetic contribution to sensitization
and disease.
NIOSH is in a unique position to accomplish this research for a
number of reasons: (a) It has a successful collaboration with the
leading manufacturer of beryllium in the US. This has allowed us to
establish well-characterized worker cohorts within the beryllium
industry. (b) It is conducting industrial hygiene research that should
significantly improve workplace-based exposure assessment methods. This
research will allow characterization of jobs and tasks by
physicochemical characteristics, leading to an estimation of dose
rather than mass concentration-based exposure. (c) It has pioneered the
evaluation of the dermal exposure route in the beryllium sensitization
process. (d) It has developed and improved genetic research that will
contribute to the understanding of risk variability in sensitization
and disease, as well as discerning the underlying mechanisms. (e) NIOSH
has the institutional stability to continue longitudinal evaluations of
health outcomes in relation to exposure and genetic risk factors.
NIOSH has been conducting this survey of beryllium workers for
three years and this extension will allow for completion of the data
collection on former workers. Workers are asked to complete an
interviewer administered medical and work history questionnaire and to
give a blood sample. Without medical and work history data on former
workers, NIOSH staff will be unable to conduct the necessary research
to make recommendations for preventing beryllium sensitization and
disease. Follow-up on this cohort will provide invaluable information
on the natural history of disease, gene-gene, and gene-environment
interactions, which can become the basis for prevention policy at both
company and government levels.
There are no costs to the respondents other than their time. The
only change to this previously approved project is a decrease in the
burden hours because the proposed data collection is almost complete.
The total estimated annualized burden hours are 50.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Former Workers............................................... 100 1 30/60
----------------------------------------------------------------------------------------------------------------
[[Page 9828]]
Dated: February 21, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.1
[FR Doc. E6-2710 Filed 2-24-06; 8:45 am]
BILLING CODE 4163-18-P
