Attachment L -- Federal Register Notice

Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices
Program Act of 2000 (EEOICPA),
42 U.S.C. 7384q. On June 3, 2011, the
Secretary of HHS determined that the
following class of employees does not
meet the statutory criteria for addition
to the SEC as authorized under
EEOICPA:
All Atomic Weapons Employees who
worked at Dow Chemical Company in
Madison, Illinois, from January 1, 1961
through November 30, 2007.

of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone
1–877–222–7570. Information requests
can also be submitted by e-mail to
DCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.

FOR FURTHER INFORMATION CONTACT:

Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 1–
877–222–7570. Information requests can
also be submitted by e-mail to
DCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2011–15821 Filed 6–23–11; 8:45 am]
BILLING CODE 4163–19–P

[FR Doc. 2011–15826 Filed 6–23–11; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination Concerning a Petition
To Add a Class of Employees to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).

AGENCY:

ACTION:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

HHS gives notice of a
determination concerning a petition to
add a class of employees from the Bliss
& Laughlin Steel Company located at
110 Hopkins Street, Buffalo, New York,
to the Special Exposure Cohort (SEC)
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 (EEOICPA), 42
U.S.C. 7384q. On June 3, 2011, the
Secretary of HHS determined that the
following class of employees does not
meet the statutory criteria for addition
to the SEC as authorized under
EEOICPA:

SUMMARY:

Determination Concerning a Petition
To Add a Class of Employees to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:

HHS gives notice of a
determination concerning a petition to
add a class of employees from the
Chapman Valve Manufacturing
Company (i.e., Building 23 and Dean
Street facility) in Indian Orchard,
Massachusetts, to the Special Exposure
Cohort (SEC) under the Energy
Employees Occupational Illness
Compensation Program Act of 2000
(EEOICPA), 42 U.S.C. 7384q. On June 3,
2011, the Secretary of HHS determined
that the following class of employees
does not meet the statutory criteria for
addition to the SEC as authorized under
EEOICPA:

SUMMARY:

srobinson on DSK4SPTVN1PROD with NOTICES

Notice.

All Atomic Weapons Employees who
worked at the Bliss & Laughlin Steel
Company located at 110 Hopkins Street,
Buffalo, New York, for the period from
January 1, 1951, through December 31, 1952,
and/or during the residual period from
January 1, 1953, through December 31, 1998.
FOR FURTHER INFORMATION CONTACT:

Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 1–
877–222–7570. Information requests can
also be submitted by e-mail to
DCAS@CDC.GOV.

All Atomic Weapons Employees who were
monitored, or should have been monitored
for radiological exposures while performing
Atomic Energy Commission work at the
Chapman Valve Manufacturing Company
(i.e., Building 23 and Dean Street facility) in
Indian Orchard, Massachusetts, from January
1, 1948 through December 31, 1949, and from
January 1, 1991 through December 31, 1993.

John Howard,
Director, National Institute for Occupational
Safety and Health.

FOR FURTHER INFORMATION CONTACT:

[FR Doc. 2011–15833 Filed 6–23–11; 8:45 am]

Stuart L. Hinnefeld, Director, Division

BILLING CODE 4163–19–P

VerDate Mar<15>2010

19:06 Jun 23, 2011

Jkt 223001

PO 00000

Frm 00063

Fmt 4703

Sfmt 4703

37115

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination Concerning a Petition
To Add a Class of Employees to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:

HHS gives notice of a
determination concerning a petition to
add a class of employees from the Wah
Chang facility in Albany, Oregon, to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000 (EEOICPA), 42 U.S.C. 7384q. On
June 3, 2011, the Secretary of HHS
determined that the following class of
employees does not meet the statutory
criteria for addition to the SEC as
authorized under EEOICPA:

SUMMARY:

All Atomic Weapons Employees who
worked in any building at the Wah Chang
facility in Albany, Oregon, for the entire
residual contamination period from January
1, 1973, through October 31, 2009.
FOR FURTHER INFORMATION CONTACT:

Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 1–
877–222–7570. Information requests can
also be submitted by e-mail to
DCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2011–15827 Filed 6–23–11; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘Patient
Safety Organization Certification for

SUMMARY:

E:\FR\FM\24JNN1.SGM

24JNN1

37116

Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices

Initial Listing and Related Forms,
Patient Safety Confidentiality Complaint
Form, and Common Formats.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on April 18th, 2011 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by July 25, 2011.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:

Proposed Project

srobinson on DSK4SPTVN1PROD with NOTICES

Patient Safety Organization
Certification for Initial Listing and
Related Forms, Patient Safety
Confidentiality Complaint Form, and
Common Formats
The Patient Safety and Quality
Improvement Act of 2005 (hereafter the
Patient Safety Act), 42 U.S.C. 299b–21
to 299b–26, was enacted in response to
growing concern about patient safety in
the United States and the Institute of
Medicine’s 1999 report, To Err is
Human: Building a Safer Health System.
The goal of the statute is to improve
patient safety by providing an incentive
for health care providers to work
voluntarily with experts in patient
safety to reduce risks and hazards to the
safety and quality of patient care. The
Patient Safety Act signifies the Federal
Government’s commitment to fostering
a culture of patient safety among health
care providers; it offers a mechanism for
creating an environment in which the
causes of risks and hazards to patient
safety can be thoroughly and honestly
examined and discussed without fear of
penalties and liabilities. It provides for
the voluntary formation of Patient
Safety Organizations (PSOs) that can
collect, aggregate, and analyze
confidential information reported

VerDate Mar<15>2010

19:06 Jun 23, 2011

Jkt 223001

voluntarily by health care providers. By
analyzing substantial amounts of patient
safety event information across multiple
institutions, PSOs will be able to
identify patterns of failures and propose
measures to eliminate or reduce patient
safety risks and hazards.
In order to implement the Patient
Safety Act, the Department of Health
and Human Services (HHS) issued the
Patient Safety and Quality Improvement
Final Rule (hereafter the Patient Safety
Rule), 42 CFR part 3, which became
effective on January 19, 2009. The
Patient Safety Rule establishes a
framework by which hospitals, doctors,
and other health care providers may
voluntarily report information to PSOs,
on a privileged and confidential basis,
for the aggregation and analysis of
patient safety events. In addition, the
Patient Safety Rule outlines the
requirements that entities must meet to
become PSOs and the process by which
the Secretary of HHS (hereafter the
Secretary) will review and accept
certifications and list PSOs.
In addition to the Patient Safety Act
and the Patient Safety Rule, HHS issued
Guidance Regarding Patient Safety
Organizations’ Reporting Obligations
and the Patient Safety and Quality
Improvement Act of 2005 (hereafter
Guidance) on December 30, 2010. The
Guidance addresses questions that have
arisen regarding the obligations of PSOs
where they or the organization of which
they are a part are legally obligated
under the Federal Food, Drug, and
Cosmetic Act (FDCA) and its
implementing regulations to report
certain information to the Food and
Drug Administration (FDA) and to
provide FDA with access to its records,
including access during an inspection of
its facilities. This Guidance applies to
all entities that seek to be or are PSOs
or component PSOs that have
mandatory FDA-reporting obligations
under the FDCA and its implementing
regulations (‘‘FDA-regulated reporting
entities’’) or are organizationally related
to such FDA-regulated reporting entities
(e.g., parent organizations, subsidiaries,
sibling organizations).
When PSOs meet the requirements of
the Patient Safety Act, the information
collected and the analyses and
deliberations regarding the information
receive Federal confidentiality and
privilege protections under this
legislation. The Secretary delegated
authority to the Director of the Office for
Civil Rights (OCR) to enforce the
confidentiality protections of the Patient
Safety Act. 71 FR 28701–28702 (May 17,
2006). OCR is responsible for enforcing
protections regarding patient safety
work product (PSWP), which generally

PO 00000

Frm 00064

Fmt 4703

Sfmt 4703

includes information that could
improve patient safety, health care
quality, or health care outcomes and (1)
is assembled or developed by a provider
for reporting to a PSO and is reported
to a PSO or (2) is developed by a PSO
for the conduct of patient safety
activities. Civil money penalties may be
imposed for knowing or reckless
impermissible disclosures of PSWP.
AHRQ implements and administers the
rest of the Patient Safety Act’s
provisions.
Pursuant to 42 CFR 3.102, an entity
that seeks to be listed as a PSO by the
Secretary must certify that it meets
certain requirements and, upon listing,
will meet other criteria. To remain listed
for renewable three-year periods, a PSO
must recertify that it meets these
obligations and will continue to meet
them while listed. The Patient Safety
Act and Patient Safety Rule also impose
other obligations, discussed below, that
a PSO must meet to remain listed. In
order for the Secretary to administer the
Patient Safety Act and Rule, the entities
seeking to be listed and to remain listed
must complete the proposed forms
attached hereto.
Method of Collection
With this submission, AHRQ is
requesting approval of the following
proposed administrative forms:
1. PSO Certification for Initial Listing
Form. This form, which is to be
completed by an entity seeking to be
listed by the Secretary as a PSO for an
initial three-year period, contains
certifications that the entity meets the
requirements for listing as a PSO, in
accordance with 42 U.S.C. 299b–24(a)(1)
and 42 CFR 3.102.
2. PSO Certification for Continued
Listing Form. In accordance with
42 U.S.C. 299b–24(a)(2) and the Patient
Safety Rule, this form is to be completed
by a listed PSO seeking continued
listing as a PSO by the Secretary for an
additional three year period.
3. PSO Two Bona Fide Contracts
Requirement Certification Form. To
remain listed, a PSO must have
contracts with more than one provider,
within successive 24 month periods,
beginning with the date of its initial
listing. 42 U.S.C. 299(b)(1)(C). This form
is to be used by a PSO to certify whether
it has met this requirement.
4. PSO Disclosure Statement Form. A
PSO must submit this form when it (i)
has a Patient Safety Act contract witha health care provider and (ii) it has
financial, reporting, and contractual
relationships with that contracting
provider or is not independent of that
contracting provider. 42 U.S.C. 299b–24;
42 CFR 3.102(d)(2).

E:\FR\FM\24JNN1.SGM

24JNN1

37117

Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices
5. PSO Information Form. This form
gathers information on PSOs and the
type of healthcare providers and settings
that they are working with to conduct
patient safety activities in order to
improve patient safety. It is designed to
collect a minimum level of data
necessary to develop aggregate statistics
relating to the Patient Safety Act,
including types of institutions
participating and their general location
in the US. This information will be
included in AHRQ’s annual quality
report, as required by 42 U.S.C. 299b–
23(c).
OCR is requesting approval of the
following administrative form:
Patient Safety Confidentiality
Complaint Form. The purpose of this
collection is to allow OCR to collect the
minimum information needed from
individuals filing patient safety
confidentiality complaints with our
office so that we have a basis for initial
processing of those complaints.
In addition, AHRQ is requesting
approval for a set of common definitions
and reporting formats (hereafter
Common Formats). Pursuant to
42 U.S.C. 299b–23(b), AHRQ
coordinates the development of the
Common Formats that allow PSOs and
health care providers to voluntarily
collect and submit standardized
information regarding patient safety
events.
Estimated Annual Respondent Burden
While there are a number of
information collection forms described
below, they will be implemented at
different times and frequency due to the
voluntary nature of seeking listing as a
PSO and using the Common Formats.
Exhibit 1 shows the estimated
annualized burden hours for the
respondent to provide the requested
information, and Exhibit 2 shows the
estimated annualized cost burden
associated with the respondents’ time to

provide the requested information. The
total burden hours are estimated to be
75,764 hours annually and the total cost
burden is estimated to be $2,538,852
annually.
PSO Certification for Initial Listing
Form
The average annual burden for the
collection of information requested by
the certification forms for initial listing
is based upon a total average estimate of
15 respondents per year and an
estimated time of 18 hours per response.
This collection of information takes
place on an ongoing basis.
Certification for Continued Listing
Form
The average annual burden for the
collection of information requested by
the certification form for continued
listing is based upon the estimate that
90% of the listed PSOs during the 3
years of this clearance, or 24 PSOs
annually, will submit forms with an
estimated time of eight hours per
response. The Certification for
Continued Listing Form will be
completed by any interested PSO at
least 75 days before the end of its
current three-year listing period.
Two Bona Fide Contracts Requirement
Certification
The average annual burden for the
collection of information requested by
the two-contract requirement is based
upon an estimate of 40 respondents per
year and an estimated one hour per
response. This collection of information
takes place when the PSO notifies the
Secretary that it has entered into two
contracts.
Disclosure Statement Form
AHRQ assumes that only a small
percentage of entities will need to file a
disclosure form. However, AHRQ is
providing a high estimate of 7

respondents annually and thus
presumably overestimating respondent
burden. The average annual burden
estimate of 21 hours for the collection
of information requested by the
disclosure form is based upon an
estimated three hours per response. This
information collection takes place when
a PSO first reports having any of the
specified types of additional
relationships with a health care
provider with which it has a contract to
carry out patient safety activities.
Information Form
The overall annual burden estimate of
240 hours for the collection of
information requested by the PSO
Information Form is based upon an
estimate of 80 respondents per year and
an estimated three hours per response.
This information collection will begin
in 2011; newly listed PSOs will first
report in the calendar year after their
listing by the HHS Secretary.
Patient Safety Confidentiality
Complaint Form
The overall annual burden estimate of
1 hour for the collection of information
requested by the form is based on an
estimate of two respondents per year
and an estimated 20 minutes per
response. OCR’s information collection
using this form will not begin until after
there is at least one PSO receiving and
generating PSWP and there is an
allegation of a violation of the statutory
protection of PSWP.
Common Formats
AHRQ estimates that 5% FTE of a
Patient Safety Manager at a hospital will
be spent to administer the Common
Formats, which is approximately 100
hours a year. AHRQ estimates the
number of hospitals using Common
Formats in the first year as 500, then
750 in year 2, and 1000 in year 3, for
an annual average of 750 over 3 years.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

srobinson on DSK4SPTVN1PROD with NOTICES

Form

Number of
responses
per
respondent

Hours per
response

Total burden
hours

Patient Safety Organization Certification for Initial Listing Form .....................
Certification for Continued Listing Form ..........................................................
Two Bona Fide Contracts Requirement Form .................................................
Disclosure Statement Form .............................................................................
Information Form .............................................................................................
Patient Safety Confidentiality Complaint Form ................................................
Common Formats ............................................................................................

15
24
40
7
80
2
750

1
1
1
1
1
1
1

18
8
1
3
3
20/60
100

270
192
40
21
240
1
75,000

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

918

NA

NA

75,764

VerDate Mar<15>2010

19:06 Jun 23, 2011

Jkt 223001

PO 00000

Frm 00065

Fmt 4703

Sfmt 4703

E:\FR\FM\24JNN1.SGM

24JNN1

37118

Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form

Total burden
hours

Average
hourly wage
rate*

Total cost
burden

Certification for Initial Listing Form ..................................................................
Certification for Continued Listing Form ..........................................................
Two Bona Fide Contracts Requirement Form .................................................
Disclosure Statement Form .............................................................................
Information Form .............................................................................................
Patient Safety Confidentiality Complaint Form ................................................
Common Formats ............................................................................................

15
24
40
7
80
2
750

270
192
40
21
240
1
75,000

33.51
33.51
33.51
33.51
33.51
33.51
33.51

9,048
6,434
$1,340
704
8,042
34
2,513,250

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

918

75,764

NA

2,538,852

* Based upon the mean of the hourly wages for healthcare practitioner and technical occupation, National Compensation Survey, May 2009,
‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’

Estimated Annual Costs to the Federal
Government
a. AHRQ
The total cost to the Federal
Government for the PSO forms and
Common Formats is $1,737,390 per
year, including project management and
support for the review and
administration of the PSO forms and the
development and maintenance of the
Common Formats.
b. OCR
Through an interagency agreement
(IAA), OCR provides management for
and support of the enforcement of the
confidentiality protections of the Patient
Safety Act and the Patient Safety Rule.
The cost of this IAA is approximately
$300,000 annually.

srobinson on DSK4SPTVN1PROD with NOTICES

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following:
(a) Whether the proposed collection of
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) 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 upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.

VerDate Mar<15>2010

19:06 Jun 23, 2011

Jkt 223001

Dated: June 10, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–15578 Filed 6–23–11; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number: NIOSH–243]

Manual Materials Handling (MMH)
Workshop
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of public meeting.
AGENCY:

The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC) in
partnership with the University of
Cincinnati, Department of
Environmental Health, will be holding a
two-day Manual Materials Handling
(MMH) Workshop. The Workshop is a
National Occupational Research Agenda
(NORA) activity organized by the
Wholesale and Retail Trade Sector and
the Transportation, Warehouse and
Utilities Sector. The MMH Workshop
goal is to stimulate through roundtable
discussions the wider adoption of
current, effective MMH equipment, and
the development of the next generation
of MMH equipment for the purposes of
reducing both worker fatigue from
overexertion and strains/sprains, as well
as improving overall efficiency. The
purpose of MMH Workshop is to
develop cost effective engineering
solutions for manual materials handling

SUMMARY:

PO 00000

Frm 00066

Fmt 4703

Sfmt 4703

jobs in Retail, Wholesale and
Warehouse industries.
DATES: The public meeting will be held
8 a.m. to 5 p.m., Eastern Daylight Time,
October 11 through 12, 2011.
Place: Hyatt Regency Cincinnati,
151 West Fifth Street, Cincinnati, Ohio
45202, telephone (513) 579–1234.
SUPPLEMENTARY INFORMATION:
Status: Attendance is limited only by
the space available. The meeting room
accommodates 225 people. If interested
in attending the meeting, please contact
the NIOSH Docket Office at
nioshdocket@cdc.gov or telephone
(513)533–8611. Priority for attendance
will be given to the Loss Prevention/
Safety representatives from businesses
within the Retail, Wholesale and
Warehouse industries. Other requests to
attend the meeting will then be
accommodated on a first-come basis.
Registration and information on the
Workshop can be found at the
University of Cincinnati Web site
http://www.eh.uc.edu/MMHworkshop.
Attendees: Industry/safety/loss
prevention representatives from the
Retail, Wholesale and Warehouse
industries who believe there should be
a better way of moving materials and
containers in their businesses.
Manufacturers/vendors of MMH
equipment who desire to partner with
one or more Retail, Wholesale and
Warehouse industries to explore/
develop the next generation of MMHassisted equipment.
Practitioners/researchers who seek to
partner with businesses in
implementing and evaluating MMH
engineering solutions to lifting jobs in
the Retail, Wholesale and Warehouse
industries.
The public, insurance experts,
Workers’ Compensation representatives,
and government representatives who are
interested in reducing the injuries
associated with manual lifting in jobs
found in the Retail, Wholesale and
Warehouse industries.

E:\FR\FM\24JNN1.SGM

24JNN1