Proposed Data Collections Submitted for Public Comment and Recommendations, 54151-54152 [2010-22053]
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srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices
Hours: 6,000 (For policy questions
regarding this collection contact Diane
Ross at 410–786–1169. For all other
issues call 410–786–1326.)
4. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Beneficiary
Customer Service Feedback Survey;
Use: The Centers for Medicare and
Medicaid Services (CMS) stresses a
continuing need for setting customer
service goals that include providing
accurate, timely, and relevant
information to its customers. With these
goals in mind, the Division of Medicare
Ombudsman Assistance (DMOA) needs
to periodically survey its customers that
correspond with CMS to ensure that the
needs of Medicare beneficiaries are
being met. This survey will be used to
measure overall satisfaction of the
customer service that the DMOA
provides to Medicare beneficiaries and
their representatives. The need for this
previously OMB approved information
collection is to further meet the
customer service goals that the CMS has
established and to continue to create a
rapport within the Medicare
community. Form Number: CMS–10068
(OMB#: 0938–0894); Frequency:
Quarterly; Affected Public: Individuals
and Households; Number of
Respondents: 2,242 Total Annual
Responses: 2,242; Total Annual Hours:
224. (For policy questions regarding this
collection contact Nancy Conn at 410–
786–8374. For all other issues call 410–
786–1326.)
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: End Stage Renal
Disease Medical Evidence Report
Medicare Entitlement and/or Patient
Registration; Use: The End Stage Renal
Disease (ESRD) Medical Evidence
Report is completed for all ESRD
patients either by the first treatment
facility or by a Medicare-approved
ESRD facility when it is determined by
a physician that the patient’s condition
has reached that stage of renal
impairment that a regular course of
kidney dialysis or a kidney transplant is
necessary to maintain life. The data
reported on the CMS–2728 is used by
the Federal Government, ESRD
Networks, treatment facilities,
researchers and others to monitor and
assess the quality and type of care
provided to end stage renal disease
beneficiaries. The data collection
captures the specific medical
information required to determine the
Medicare medical eligibility of End
Stage Renal Disease claimants. Form
Number: CMS–2728 (OMB#: 0938–
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15:33 Sep 02, 2010
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0046); Frequency: Occasionally;
Affected Public: Individuals or
households; Number of Respondents:
100,000; Total Annual Responses:
100,000; Total Annual Hours: 75,000.
(For policy questions regarding this
collection contact Connie Cole at 410–
786–0257. For all other issues call 410–
786–1326.)
6. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Conditions of
Coverage for Organ Procurement
Organizations and Supporting
Regulations in 42 CFR, Sections
486.301–.348; Use: Section 1138(b) of
the Social Security Act, as added by
section 9318 of the Omnibus Budget
Reconciliation Act of 1986 (Pub. L. 99–
509), sets forth the statutory
qualifications and requirements that
OPOs must meet in order for the costs
of their services in procuring organs for
transplant centers to be reimbursable
under the Medicare and Medicaid
programs. An OPO must be certified and
designated by the Secretary as an OPO
and must meet performance-related
standards prescribed by the Secretary.
The corresponding regulations are
found at 42 CFR Part 486 (Conditions
for Coverage of Specialized Services
Furnished by Suppliers) under subpart
G (Requirements for Certification and
Designation and Conditions for
Coverage: Organ Procurement
Organizations).
Since each OPO has a monopoly on
organ procurement within its donation
service area, CMS must hold OPOs to
high standards. Collection of this
information is necessary for CMS to
assess the effectiveness of each OPO and
determine whether it should continue to
be certified as an OPO and designated
for a particular donation service area by
the Secretary or replaced by an OPO
that can more effectively procure organs
within the donation service area. Form
Number: CMS–R–13 (OMB#: 0938–
0688); Frequency: Occasionally;
Affected Public: Not-for-profit
institutions; Number of Respondents:
79; Total Annual Responses: 79; Total
Annual Hours: 15,178. (For policy
questions regarding this collection
contact Diane Corning at 410–786–8486.
For all other issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
54151
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on October 4, 2010.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395–
6974, E-mail:
OIRA_submission@omb.eop.gov.
Dated: August 26, 2010.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–21721 Filed 9–2–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–10GX]
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 Maryam I. Daneshvar,
Ph.D., CDC Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail 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
be received within 60 days of this
notice.
E:\FR\FM\03SEN1.SGM
03SEN1
54152
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices
Proposed Project
Persistence of Viable Influenza Virus
in Aerosols—New—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Institute for
Occupational Safety and Health
(NIOSH) is authorized to conduct
research to advance the health and
safety of workers under Section 20(a)(1)
of the 1970 Occupational Safety and
Health Act.
Influenza continues to be a major
public health concern because of the
substantial health burden from seasonal
influenza and the potential for a severe
pandemic. Although influenza is known
to be transmitted by infectious
secretions, these secretions can be
transferred from person to person in
many different ways, and the relative
importance of the different pathways is
not known. The likelihood of the
transmission of influenza virus by small
infectious airborne particles produced
during coughing and breathing is
particularly unclear. The question of
airborne transmission is especially
important in healthcare facilities, where
influenza patients tend to congregate
during influenza season, because it
directly impacts the infection control
and personal protective measures that
should be taken by healthcare workers.
The purpose of this study is to
measure the amount of viable influenza
virus in airborne particles that are
produced by patients when they cough,
and the size and quantity of the
particles carrying the virus. A better
understanding of the amount of
potentially infectious material released
by patients and the size of the particles
carrying the virus will assist in
determining the possible role of
airborne transmission in the spread of
influenza and in devising measures to
prevent it.
Volunteer participants will be
recruited by a test coordinator using a
flyer describing the study. Interested
potential participants will be screened
using a short health questionnaire to
verify that they have influenza-like
symptoms and that they do not have any
medical conditions that would preclude
their participation. Qualified
participants who agree to participate in
the study will be asked to read and sign
an informed consent form. Based on a
previous study using similar forms, we
estimate that the health questionnaire
will require about 5 minutes to
complete, and the informed consent
form will take about 20 minutes to read
and sign. Once the informed consent
form is signed, the participant will be
asked to cough into an aerosol particle
collection system, and the airborne
particles produced by the participant
during coughing will be collected and
tested.
ESTIMATED ANNUAL BURDEN HOURS
Average
burden per
response
(in hours)
Form
Initial participants ..............................
Qualified participants ........................
Health questionnaire ........................
Informed Consent form ....................
132
120
1
1
5/60
20/60
11
40
Total ...........................................
...........................................................
........................
........................
........................
51
Dated: August 27, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–22053 Filed 9–2–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0290]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NEURX DIAPHRAGM
PACING SYSTEM
AGENCY:
Food and Drug Administration,
srobinson on DSKHWCL6B1PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for NEURX
DIAPHRAGM PACING SYSTEM and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
SUMMARY:
VerDate Mar<15>2010
15:33 Sep 02, 2010
Jkt 220001
Number of
respondents
Number of
responses per
respondent
Type of
respondent
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
medical device.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
PO 00000
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Fmt 4703
Sfmt 4703
Total burden
hours
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a medical device will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(3)(B).
E:\FR\FM\03SEN1.SGM
03SEN1
]]>Agencies
[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Notices]
[Pages 54151-54152]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-10-10GX]
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 Maryam I. Daneshvar, Ph.D., CDC Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
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 be received
within 60 days of this notice.
[[Page 54152]]
Proposed Project
Persistence of Viable Influenza Virus in Aerosols--New--National
Institute for Occupational Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The National Institute for Occupational Safety and Health (NIOSH)
is authorized to conduct research to advance the health and safety of
workers under Section 20(a)(1) of the 1970 Occupational Safety and
Health Act.
Influenza continues to be a major public health concern because of
the substantial health burden from seasonal influenza and the potential
for a severe pandemic. Although influenza is known to be transmitted by
infectious secretions, these secretions can be transferred from person
to person in many different ways, and the relative importance of the
different pathways is not known. The likelihood of the transmission of
influenza virus by small infectious airborne particles produced during
coughing and breathing is particularly unclear. The question of
airborne transmission is especially important in healthcare facilities,
where influenza patients tend to congregate during influenza season,
because it directly impacts the infection control and personal
protective measures that should be taken by healthcare workers.
The purpose of this study is to measure the amount of viable
influenza virus in airborne particles that are produced by patients
when they cough, and the size and quantity of the particles carrying
the virus. A better understanding of the amount of potentially
infectious material released by patients and the size of the particles
carrying the virus will assist in determining the possible role of
airborne transmission in the spread of influenza and in devising
measures to prevent it.
Volunteer participants will be recruited by a test coordinator
using a flyer describing the study. Interested potential participants
will be screened using a short health questionnaire to verify that they
have influenza-like symptoms and that they do not have any medical
conditions that would preclude their participation. Qualified
participants who agree to participate in the study will be asked to
read and sign an informed consent form. Based on a previous study using
similar forms, we estimate that the health questionnaire will require
about 5 minutes to complete, and the informed consent form will take
about 20 minutes to read and sign. Once the informed consent form is
signed, the participant will be asked to cough into an aerosol particle
collection system, and the airborne particles produced by the
participant during coughing will be collected and tested.
Estimated Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Initial participants.......... Health 132 1 5/60 11
questionnaire.
Qualified participants........ Informed Consent 120 1 20/60 40
form.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 51
----------------------------------------------------------------------------------------------------------------
Dated: August 27, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-22053 Filed 9-2-10; 8:45 am]
BILLING CODE 4163-18-P
