Agency Information Collection Activities: Proposed Collection: Comment Request, 9029-9030 [2011-3528]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices
professionally by gaining a better
understanding of industry processes and
procedures.
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
mstockstill on DSKH9S0YB1PROD with NOTICES
796–0700, e-mail:
elizabeth.duvallmiller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
III. Site Selection
All travel expenses associated with
the site tours will be the responsibility
of CDER; therefore, selection will be
based on the availability of funds and
resources for each fiscal year. Selection
will also be based on firms having a
favorable facility status as determined
by FDA’s Office of Regulatory Affairs
District Offices in the firms’ respective
regions. Firms interested in offering a
site tour or learning more about this
training opportunity should respond by
submitting a proposed agenda to Beth
Duvall-Miller (see DATES and FOR
FURTHER INFORMATION CONTACT).
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
VerDate Mar<15>2010
17:10 Feb 15, 2011
Jkt 223001
Dated: February 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3461 Filed 2–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB), under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
9029
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Ryan White HIV/
AIDS Program Core Medical Services
Waiver Application Requirements
(OMB No. 0915–0307)—Extension
Title XXVI, Section 2671 of the Public
Health Service (PHS) Act, as amended
by the Ryan White HIV/AIDS Treatment
Extension Act of 2009 (Ryan White HIV/
AIDS Program), requires that grantees
expend 75 percent of Parts A, B, and C
Funds on core medical services,
including antiretroviral drugs for
individuals with HIV/AIDS, identified
and eligible under the legislation. In
order for Grantees under Parts A, B, and
C to be exempted from the 75 percent
core medical services requirement, they
must request and receive a waiver from
HRSA, as required in the Act.
HRSA utilizes standards for granting
waivers of the core medical services
requirement for the Ryan White HIV/
AIDS Program. These standards meet
the intent of the Ryan White HIV/AIDS
Program to increase access to core
medical services, including
antiretroviral drugs for persons with
HIV/AIDS, and to ensure that grantees
receiving waivers demonstrate the
availability of such services for
individuals with HIV/AIDS, identified
and eligible under Title XXVI of the
PHS Act. The core medical services
waiver uniform standard and waiver
request process will apply to Ryan
White HIV/AIDS Program Grant Awards
under Parts A, B, and C of Title XXVI
of the PHS Act. Core medical services
waivers will be effective for a 1-year
period that is consistent with the grant
award period.
Grantees must submit a waiver
request with the annual grant
application containing the certifications
and documentation which will be
utilized by HRSA in making
determinations regarding waiver
requests. Grantees must provide
evidence that all of the core medical
services listed in the statute, regardless
of whether such services are funded by
the Ryan White HIV/AIDS Program, are
available to all individuals with HIV/
AIDS, identified and eligible under Title
XXVI of the PHS Act in the service area
within 30 days.
The annual estimate of burden is as
follows:
E:\FR\FM\16FEN1.SGM
16FEN1
9030
Federal Register / Vol. 76, No. 32 / Wednesday, February 16, 2011 / Notices
Number of
respondents
Application
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Waiver Request ...................................................................
10
1
10
6.5
65
Total ..............................................................................
10
1
10
6.5
65
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 30 days of
this notice.
Dated: February 10, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–3528 Filed 2–15–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
Advisory Commission on Childhood
Vaccines; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: Advisory Commission on
Childhood Vaccines (ACCV).
Date And Time: March 3, 2011, 9 a.m.
to 5 p.m. EDT, March 4, 2011, 9 a.m. to
12 p.m. EDT.
Place: Parklawn Building (and via
audio conference call), Conference
Rooms G & H, 5600 Fishers Lane,
Rockville, MD 20857.
The ACCV will meet on Thursday,
March 3 from 9 a.m. to 5 p.m. (EDT) and
on Friday, March 4 from 9 a.m. to 12
p.m. (EDT). The public can join the
meeting via audio conference call by
dialing 1–800–369–3104 on March 3
and March 4 and providing the
following information:
Leader’s Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the
March meeting will include, but are not
limited to: updates from the Division of
Vaccine Injury Compensation (DVIC),
Department of Justice (DOJ), National
Vaccine Program Office, Immunization
Safety Office (Centers for Disease
Control and Prevention), National
Institute of Allergy and Infectious
Diseases (National Institutes of Health),
Center for Biologics, Evaluation and
Research (Food and Drug
Administration), a discussion on the
VICP outreach efforts, and a review of
VerDate Mar<15>2010
17:10 Feb 15, 2011
Jkt 223001
Vaccine Information Statements (VISs).
A draft agenda and additional meeting
materials will be posted on the ACCV
Web site (https://www.hrsa.gov/
vaccinecompensation/accv.htm) prior to
the meeting. Agenda items are subject to
change as priorities dictate.
Public Comment: Persons interested
in providing an oral presentation should
submit a written request, along with a
copy of their presentation to: Annie
Herzog, DVIC, Healthcare Systems
Bureau (HSB), Health Resources and
Services Administration (HRSA), Room
11C–26, 5600 Fishers Lane, Rockville,
Maryland 20857 or e-mail:
aherzog@hrsa.gov. Requests should
contain the name, address, telephone
number, e-mail address, and any
business or professional affiliation of
the person desiring to make an oral
presentation. Groups having similar
interests are requested to combine their
comments and present them through a
single representative. The allocation of
time may be adjusted to accommodate
the level of expressed interest. DVIC
will notify each presenter by e-mail,
mail or telephone of their assigned
presentation time. Persons who do not
file an advance request for a
presentation, but desire to make an oral
statement, may announce it at the time
of the comment period. Public
participation and ability to comment
will be limited to space and time as it
permits.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the ACCV should contact Annie Herzog,
DVIC, HSB, HRSA, Room 11C–26, 5600
Fishers Lane, Rockville, MD 20857;
telephone (301) 443–6593 or e-mail:
aherzog@hrsa.gov.
Dated: February 10, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–3527 Filed 2–15–11; 8:45 am]
BILLING CODE 4165–15–P
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Ancillary Studies in
Immunomodulation Clinical Trials (R01).
Date: March 10, 2011.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: James T. Snyder, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities/
NIAID, National Institutes of Health, 6700B
Rockledge Drive, MSC 7616, Room #3257,
Bethesda, MD 20892–7616, 301–435–1614,
james.snyder@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Genetics of Lupus.
Date: March 11, 2011.
Time: 11:30 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, 3136, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Wendy F. Davidson, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
DHHS/NIH/NIAID, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892, 301–402–
8399, davidsonw@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9029-9030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB), under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, e-mail paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (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.
Proposed Project: Ryan White HIV/AIDS Program Core Medical Services
Waiver Application Requirements (OMB No. 0915-0307)--Extension
Title XXVI, Section 2671 of the Public Health Service (PHS) Act, as
amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009
(Ryan White HIV/AIDS Program), requires that grantees expend 75 percent
of Parts A, B, and C Funds on core medical services, including
antiretroviral drugs for individuals with HIV/AIDS, identified and
eligible under the legislation. In order for Grantees under Parts A, B,
and C to be exempted from the 75 percent core medical services
requirement, they must request and receive a waiver from HRSA, as
required in the Act.
HRSA utilizes standards for granting waivers of the core medical
services requirement for the Ryan White HIV/AIDS Program. These
standards meet the intent of the Ryan White HIV/AIDS Program to
increase access to core medical services, including antiretroviral
drugs for persons with HIV/AIDS, and to ensure that grantees receiving
waivers demonstrate the availability of such services for individuals
with HIV/AIDS, identified and eligible under Title XXVI of the PHS Act.
The core medical services waiver uniform standard and waiver request
process will apply to Ryan White HIV/AIDS Program Grant Awards under
Parts A, B, and C of Title XXVI of the PHS Act. Core medical services
waivers will be effective for a 1-year period that is consistent with
the grant award period.
Grantees must submit a waiver request with the annual grant
application containing the certifications and documentation which will
be utilized by HRSA in making determinations regarding waiver requests.
Grantees must provide evidence that all of the core medical services
listed in the statute, regardless of whether such services are funded
by the Ryan White HIV/AIDS Program, are available to all individuals
with HIV/AIDS, identified and eligible under Title XXVI of the PHS Act
in the service area within 30 days.
The annual estimate of burden is as follows:
[[Page 9030]]
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Application respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Waiver Request.................. 10 1 10 6.5 65
-------------------------------------------------------------------------------
Total....................... 10 1 10 6.5 65
----------------------------------------------------------------------------------------------------------------
E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 30 days
of this notice.
Dated: February 10, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-3528 Filed 2-15-11; 8:45 am]
BILLING CODE 4165-15-P
