Agency Information Collection Activities: Submission for OMB Review; Comment Request, 1183-1184 [2011-99]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
jdjones on DSK8KYBLC1PROD with NOTICES
Drugs.’’ This public workshop is
intended to provide a forum for
discussing potential approaches toward
a track and trace system and obtaining
input from supply chain partners on
attributes and standards for the
identification, authentication, and
tracking and tracing of prescription drug
packages, and to further the Agency’s
goal of protecting public health by
securing the drug supply chain against
the introduction of counterfeit and other
substandard drugs.
DATES: The public workshop will be
held on February 15 and 16, 2011, from
9 a.m. to 5 p.m. Submit electronic or
written comments on the posted
information or on the workshop to the
docket by April 16, 2011.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
room 1503, Silver Spring, MD 20993. To
register for the public meeting, e-mail
your registration information to
drug.trackandtrace@fda.hhs.gov. See
section III of this document for
registration details. Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in the brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Connie Jung, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–4830, e-mail:
connie.jung@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Since the formation of the first
Counterfeit Drug Task Force in 2003,
FDA has strongly advocated for a multilayered approach to securing the supply
chain and protecting consumers from
the threats posed by counterfeit drugs.
The ability to track and trace finished
drug products in the supply chain plays
a significant role in providing
transparency and accountability in the
drug supply chain. On September 27,
2007, the Food and Drug Administration
Amendments Act of 2007 (FDAAA)
(Pub. L. 110–85) was signed into law.
Section 913 of this legislation created
section 505D of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act),
which requires the Secretary of Health
and Human Services (the Secretary) to
develop standards and identify and
validate effective technologies for the
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
purpose of securing the drug supply
chain against counterfeit, diverted,
subpotent, substandard, adulterated,
misbranded, or expired drugs. In
addition, section 505D of the FD&C Act
directs the Secretary to consult with
specific entities to prioritize and
develop standards for identification,
validation, authentication, and tracking
and tracing of prescription drugs.
In March 2010, FDA issued a final
guidance for industry which describes
the Agency’s current recommendation
for standardized numerical
identification (also known as
serialization) for prescription drug
packages (Standards for Securing the
Drug Supply Chain—Standardized
Numerical Identification for
Prescription Drug Packages, Guidance
for Industry—Final Guidance 1). This
guidance is intended to be the first of
several steps that FDA may take to
implement section 505D of the FD&C
Act and further improve the security of
the drug supply chain. As FDA
continues to work on developing
additional standards for securing the
drug supply chain, the agency is seeking
public input to ensure that we consider
information regarding all supply chain
participants.
II. Purpose of the Workshop
This public workshop is intended to
explore approaches for achieving an
effective and feasible track and trace
system for finished prescription drug
products from the supply chain
stakeholder’s point of view, including
industry and the public, and to obtain
views on system attributes and
standards that would facilitate
identification, authentication, and
tracking and tracing of prescription drug
packages. We intend to discuss with
stakeholders the necessary elements to
accomplish effective authentication and
identify desirable features of a track and
trace system. Participants will not be
asked to develop consensus opinions
during the discussion, but rather to
provide their individual perspectives.
By February 4, 2011, FDA will post
information on our Web site (https://
www.fda.gov/Drugs/DrugSafety/
ucm169828.htm) under ‘‘Standards
Development for Prescription Drug
Supply Chain Security.’’ as follows:
• Workshop agenda,
• Workshop discussion topics.
III. How To Register for the Workshop
To register for the workshop either:
(1) E-mail your registration information
to drug.trackandtrace@fda.hhs.gov or
1 https://www.fda.gov/RegulatoryInformation/
Guidances/ucm125505.htm.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
1183
(2) mail your registration information to
the contact person (see FOR FURTHER
INFORMATION CONTACT). Registration
information should include registrant
name, company or organization,
address, phone number, and email
address. Registration requests should be
received by February 1, 2011.
Registration is free. Seats are limited.
FDA may limit the numbers of
participants from each organization
based on space limitations. Registrants
will receive confirmation upon
acceptance for participation in the
workshop. Onsite registration on the
day of the meeting will be based on
space availability on the day of the
event starting at 8 a.m. If registration
reaches maximum capacity, FDA will
post a notice closing meeting
registration for the workshop on FDA’s
Web site at: https://www.fda.gov/Drugs/
DrugSafety/ucm169828.htm. If you need
special accommodations due to a
disability, please contact Connie Jung
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance.
IV. Parking Information
If you are driving to FDA’s White Oak
Campus, you should proceed to the
South East Surface Parking Lot to park
your vehicle. Shuttle service is available
from the bus shelters in the South East
Lot to Building 1. The FDA campus is
a Federal facility, therefore all meeting
attendees must enter through Building 1
and follow security procedures.
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–72 Filed 1–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the OMB for review under
the Paperwork Reduction Act of 1995:
E:\FR\FM\07JAN1.SGM
07JAN1
1184
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
Proposed Project: Ryan White HIV/
AIDS Program: Client-Level Data
Reporting System: (OMB No. 0915–
0323)—[Revision]
The Ryan White HIV/AIDS Program’s
client-level data reporting system,
entitled the Ryan White HIV/AIDS
Program Services Report or the Ryan
White Services Report (RSR), was
created in 2008 by the Health Resources
and Services Administration (HRSA). It
is designed to collect information from
grantees, as well as their subcontracted
services providers, funded under Parts
A, B, C, and D, and the Part F Minority
AIDS Initiative of the Ryan White HIV/
AIDS Treatment Extension Act of 2009
(Ryan White HIV/AIDS Program). The
Ryan White HIV/AIDS Program
provides Federal HIV/AIDS Programs in
the Public Health Service (PHS) Act
under Title XXVI with flexibility to
respond effectively to the changing HIV
epidemic, with an emphasis on
providing life-saving and life-extending
services for people living with HIV/
AIDS across this country, as well as
targeting resources to areas that have the
greatest needs.
All parts of the Ryan White HIV/AIDS
Program specify HRSA’s responsibilities
Component
in the administration of grant funds, the
allocation of funds, the evaluation of
programs for the population served, and
the improvement of the quality of care.
Accurate records of the providers
receiving Ryan White HIV/AIDS
Program funding, the services provided,
and the clients served, continue to be
critical issues for the implementation of
the legislation and are necessary for
HRSA to fulfill its responsibilities.
The RSR provides data on the
characteristics of Ryan White HIV/AIDS
Program-funded grantees, their
contracted service providers, and the
clients being served with program
funds. The Report is intended to
support clinical quality management,
performance measurement, service
delivery, and client monitoring at the
system and client levels. The reporting
system consists of two online data
forms, the Grantee Report and the
Service Provider Report, as well as a
data file containing the client-level data
elements. Data are submitted annually.
The legislation specifies grantee
accountability and linking performance
to budget. The RSR is used to ensure
compliance with the requirements of the
legislation, to evaluate the progress of
Number of
respondents
Source of funding
Grantee Report .................................
Part
Part
Part
Part
A
B
C
D
programs, to monitor grantee and
provider performance, to measure the
Government Performance and Results
Act (GPRA) and the Performance
Assessment Rating Tool (PART) goals,
and to meet reporting responsibilities to
the Department, Congress, and OMB.
In addition to meeting the goal of
accountability to Congress, clients,
advocacy groups, and the general
public, information collected through
the RSR is critical for HRSA, State and
local grantees, and individual providers
to assess the status of existing HIVrelated service delivery systems to
investigate trends in service utilization
and to identify areas of greatest need.
The estimated average annualized
hour burden is 17,975 hours per year.
Burden estimates are broken down into
burden to grantee respondents and
burden to service provider respondents.
Estimates for grantees and service
providers are further divided by the RSR
component. Estimates for grantees and
providers are based on prior experience
in collecting, maintaining, and reporting
data using the RSR and interviews with
volunteers from grantee agencies.
The response burden for grantees is
estimated as:
Responses
per grantee
Hours per
response
Total hour
burden
...............................................
...............................................
...............................................
...............................................
56
59
354
98
1
1
1
1
2.04
2.52
0.32
0.33
114
149
113
32
Subtotal .....................................
567
........................
........................
408
Total
responses
Hours per
response
The response burden for service
providers is estimated as:
Component
Number of
respondents
Responses
per provider
Service Provider Report ....................
* 2,080 ..............................................
1
* 2,080
Total hour
burden
2.30
4,784
* All providers, including providers of administrative support services and direct client services.
Number of
respondents
Responses
per provider
Total
responses
Hours per
response
Total hour
burden
Component
Electronic data system
Client Report .......................
No .......................................
Yes .....................................
56
1,822
1
1
56
1,822
106.25
3.75
5,950
6,832.5
Subtotal .......................
** 1,878
........................
** 1,878
........................
12,783
jdjones on DSK8KYBLC1PROD with NOTICES
** Providers of direct client services only.
Total Burden is 17,975.
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this Federal
Register Notice to the desk officer for
HRSA, either by e-mail to OIRA—
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
submission@omb.eop.gov or by fax to
202–395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
PO 00000
Dated: January 3, 2011.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2011–99 Filed 1–6–11; 8:45 am]
BILLING CODE 4165–15–P
Frm 00057
Fmt 4703
Sfmt 9990
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1183-1184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-99]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, call the
HRSA Reports Clearance Office on (301) 443-1129.
The following request has been submitted to the OMB for review
under the Paperwork Reduction Act of 1995:
[[Page 1184]]
Proposed Project: Ryan White HIV/AIDS Program: Client-Level Data
Reporting System: (OMB No. 0915-0323)--[Revision]
The Ryan White HIV/AIDS Program's client-level data reporting
system, entitled the Ryan White HIV/AIDS Program Services Report or the
Ryan White Services Report (RSR), was created in 2008 by the Health
Resources and Services Administration (HRSA). It is designed to collect
information from grantees, as well as their subcontracted services
providers, funded under Parts A, B, C, and D, and the Part F Minority
AIDS Initiative of the Ryan White HIV/AIDS Treatment Extension Act of
2009 (Ryan White HIV/AIDS Program). The Ryan White HIV/AIDS Program
provides Federal HIV/AIDS Programs in the Public Health Service (PHS)
Act under Title XXVI with flexibility to respond effectively to the
changing HIV epidemic, with an emphasis on providing life-saving and
life-extending services for people living with HIV/AIDS across this
country, as well as targeting resources to areas that have the greatest
needs.
All parts of the Ryan White HIV/AIDS Program specify HRSA's
responsibilities in the administration of grant funds, the allocation
of funds, the evaluation of programs for the population served, and the
improvement of the quality of care. Accurate records of the providers
receiving Ryan White HIV/AIDS Program funding, the services provided,
and the clients served, continue to be critical issues for the
implementation of the legislation and are necessary for HRSA to fulfill
its responsibilities.
The RSR provides data on the characteristics of Ryan White HIV/AIDS
Program-funded grantees, their contracted service providers, and the
clients being served with program funds. The Report is intended to
support clinical quality management, performance measurement, service
delivery, and client monitoring at the system and client levels. The
reporting system consists of two online data forms, the Grantee Report
and the Service Provider Report, as well as a data file containing the
client-level data elements. Data are submitted annually.
The legislation specifies grantee accountability and linking
performance to budget. The RSR is used to ensure compliance with the
requirements of the legislation, to evaluate the progress of programs,
to monitor grantee and provider performance, to measure the Government
Performance and Results Act (GPRA) and the Performance Assessment
Rating Tool (PART) goals, and to meet reporting responsibilities to the
Department, Congress, and OMB.
In addition to meeting the goal of accountability to Congress,
clients, advocacy groups, and the general public, information collected
through the RSR is critical for HRSA, State and local grantees, and
individual providers to assess the status of existing HIV-related
service delivery systems to investigate trends in service utilization
and to identify areas of greatest need.
The estimated average annualized hour burden is 17,975 hours per
year. Burden estimates are broken down into burden to grantee
respondents and burden to service provider respondents. Estimates for
grantees and service providers are further divided by the RSR
component. Estimates for grantees and providers are based on prior
experience in collecting, maintaining, and reporting data using the RSR
and interviews with volunteers from grantee agencies.
The response burden for grantees is estimated as:
----------------------------------------------------------------------------------------------------------------
Source of Number of Responses per Hours per Total hour
Component funding respondents grantee response burden
----------------------------------------------------------------------------------------------------------------
Grantee Report................ Part A.......... 56 1 2.04 114
Part B.......... 59 1 2.52 149
Part C.......... 354 1 0.32 113
Part D.......... 98 1 0.33 32
---------------------------------------------------------------
Subtotal..... 567 .............. .............. 408
----------------------------------------------------------------------------------------------------------------
The response burden for service providers is estimated as:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total hour
Component respondents provider responses response burden
----------------------------------------------------------------------------------------------------------------
Service Provider Report....... * 2,080......... 1 * 2,080 2.30 4,784
----------------------------------------------------------------------------------------------------------------
* All providers, including providers of administrative support services and direct client services.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total hour
Component Electronic data system respondents provider responses response burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Client Report............................. No.......................... 56 1 56 106.25 5,950
Yes......................... 1,822 1 1,822 3.75 6,832.5
-------------------------------------------------------------------------------
Subtotal................. ** 1,878 .............. ** 1,878 .............. 12,783
--------------------------------------------------------------------------------------------------------------------------------------------------------
** Providers of direct client services only.
Total Burden is 17,975.
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this Federal
Register Notice to the desk officer for HRSA, either by e-mail to
OIRA-- submission@omb.eop.gov or by fax to 202-395-6974. Please direct
all correspondence to the ``attention of the desk officer for HRSA.''
Dated: January 3, 2011.
Robert Hendricks,
Director, Division of Policy and Information Coordination.
[FR Doc. 2011-99 Filed 1-6-11; 8:45 am]
BILLING CODE 4165-15-P
