Agency Information Collection Activities: Proposed Collection: Comment Request, 71419-71420 [E7-24348]
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Federal Register / Vol. 72, No. 241 / Monday, December 17, 2007 / Notices
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Brenda R. Friend, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
ebenthall on PROD1PC69 with NOTICES
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry and FDA Review Staff:
Collection of Platelets by Automated
Methods,’’ dated December 2007. The
guidance provides to blood
establishments and FDA staff revised
recommendations for the collection of
Platelets by automated methods
(plateletpheresis). In recent years, many
improvements have been made in
automated blood cell separator
technology, platelet storage stability,
and blood cell counting methods.
Automated blood cell separator devices
are now capable of various
plateletpheresis collection procedures
including, but not limited to, collection
of double and triple platelet
components obtained during a single
procedure; use of in-process leukocyte
reduction; collection of concurrent
plasma components; and collection of
concurrent Red Blood Cell components.
This guidance replaces the draft
guidance of the same title, and
supersedes the guidance entitled
‘‘Revised Guideline for the Collection of
Platelets, Pheresis,’’ dated October 1988.
In the Federal Register of October 3,
2005 (70 FR 57609), FDA announced the
availability of the draft guidance of the
same title dated September 2005. FDA
received numerous comments on the
draft guidance and those comments
were considered as the guidance was
finalized. A summary of changes
includes: (1) Revised recommendations
for donor selection and management, (2)
revised recommendations for collection
performance qualification criteria, and
(3) revised recommendations on quality
control monitoring. The guidance
announced in this notice finalizes the
draft guidance dated September 2005.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
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The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 211 (21 CFR part 211), subpart J
(Records and Reports) have been
approved under OMB control number
0910–0139; the collections of
information in part 606 (21 CFR part
606), subpart I (Records and Reports)
have been approved under OMB control
numbers 0910–0116 and 0910–0458; the
collections of information in
§§ 606.100(b) and (c), 606.110(a),
606.121, 606.122, 21 CFR 640.25, and 21
CFR 640.27 have been approved under
OMB control number 0910–0116; the
collections of information in §§ 211.22,
211.80, 211.100(b), and 211.160 have
been approved under OMB control
number 0910–0139; the collections of
information in 21 CFR 610.2 have been
approved under OMB control number
0910–0206; and the collections of
information in 21 CFR 601.12 and
610.60 have been approved under OMB
control number 0910–0338.
III. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
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71419
publish a Federal Register notice
announcing that date.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cber/guidelines.htm or
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: December 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24385 Filed 12–14–07; 8:45 am]
BILLING CODE 4160–01–S
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 the 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 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, call the HRSA Reports
Clearance Officer at (301) 443–1129.
Comments are invited on (a) whether
the agency needs to collect the proposed
information to properly perform its
functions and whether the information
has any practical utility; (b) whether the
agency’s estimate of the burden of the
proposed collection of information is
accurate; (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 for
respondents (e.g., by using automated
collection techniques or other forms of
information technology).
Proposed Project: Ryan White HIV/
AIDS Program Part F Dental Services
Report (OMB No. 0915–0151)—
Extension
The Dental Reimbursement Program
(DRP) and the Community Based Dental
Partnership Program under Part F of the
Ryan White HIV/AIDS Program offer
funding to accredited dental education
programs to support the provision of
E:\FR\FM\17DEN1.SGM
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71420
Federal Register / Vol. 72, No. 241 / Monday, December 17, 2007 / Notices
oral health services for HIV-positive
individuals. Institutions eligible for
these programs are accredited schools of
dentistry, post-doctoral dental
education programs and dental hygiene
programs.
The DRP Application is the Dental
Services Report that schools and
programs use to apply for funding of
non-reimbursed costs incurred in
providing oral health care to patients
with HIV, or to report annual program
data. Awards are authorized under
section 2692(b) of the Public Health
Service Act (42 U.S.C. § 300ff–111(b)).
The Dental Services Report collects data
in four different areas: program
information, patient demographics and
services, funding, and training. It also
requests applicants to provide narrative
descriptions of their services and
facilities, as well as their links and
collaboration with community-based
providers of oral health services.
The primary purpose of collecting this
information annually is to verify
eligibility and determine reimbursement
amounts for DRP applicants, as well as
to document the program
accomplishments of Community-Based
Dental Partnership Program grant
recipients. This information also allows
HRSA to learn about (1) the extent of the
involvement of dental schools and
programs in treating patients with HIV,
(2) the number and characteristics of
clients who receive HIV/AIDS programsupported oral health services, (3) the
types and frequency of the provision of
these services, (4) the non-reimbursed
costs of oral health care provided to
patients with HIV, and (5) the scope of
grant recipients’ community-based
collaborations and training of providers.
In addition to meeting the goal of
accountability to Congress, clients,
advocacy groups, and the general
public, information collected in the
Dental Services Report is critical for
HRSA, State and local grantees, and
individual providers, to help assess the
status of existing HIV-related health
service delivery systems.
The reporting burden for reviewing
the Dental Services Report Instructions
and completing the Report is estimated
as:
Instrument
Number of
respondents
Responses
per respondent
Total
responses
Hours per
response
Total burden
hours
Dental Services Report ........................................................
80
1
80
20
1600
Authority: Section 2651 of the Public
Health Service Act, 42 U.S.C. 300ff–51.
Dated: December 7, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–24437 Filed 12–14–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
CFDA Number: 93.918.
Project Period: The first period of
supplemental support is from
September 30, 2007, through December
31, 2007. The anticipated second period
of supplemental support will be January
1, 2008, through December 31, 2008.
FOR FURTHER INFORMATION CONTACT:
Maria Rios, M.D, via e-mail:
mrios@hrsa.gov, or via telephone: 301–
443–0493.
services will be awarded for twelve
months. Further funding beyond
December 31, 2008, for this service area
will be competitively awarded during
the next Part C HIV Early Intervention
Services (EIS) competing application
process. The next available Part C EIS
open competing cycle will occur in
fiscal year 2009.
Health Resources and Services
Administration
Justification for the Exception to
Competition
Part C HIV Early Intervention Services
Grant
Funding critical HIV medical care and
treatment services for homeless
populations in Baltimore, MD area will
be continued through a noncompetitive
program expansion supplement to an
existing grant award to Chase Brexton
Health Services. This is a temporary
award made because the previous grant
recipient servicing this population is
unable to satisfactorily meet legislative
and program requirements. Chase
Brexton, a currently funded Ryan White
HIV/AIDS Program Part C grantee, is the
best qualified and geographically
positioned grantee able to provide the
necessary continuity of HIV care and
treatment for the targeted population.
The initial supplemental funding will
provide support for three months. Based
on satisfactory performance, continued
need, and availability of funds, a second
and final supplemental award for these
Send comments to Susan G. Queen,
PhD, HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: December 11, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–24348 Filed 12–14–07; 8:45 am]
BILLING CODE 4165–15–P
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of Noncompetitive
Program Expansion Supplemental
Award.
ebenthall on PROD1PC69 with NOTICES
AGENCY:
SUMMARY: HRSA will be providing
temporary critical HIV medical care and
treatment services through Chase
Brexton Health Services to avoid a
disruption of HIV clinical care to
homeless populations in the Baltimore,
Maryland, area.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Chase Brexton Health Services,
Baltimore, Maryland.
Amount of the Award: $73,125 (initial
three month supplement) and $300,000
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(anticipated second 12 month
supplement) to ensure ongoing clinical
services to the target population.
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BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Chief Procurement
Officer; Submission for Review;
Information Collection Request for
Various Contract Related Forms and
Regulation on Agency Protests
Office of the Chief Procurement
Officer, DHS.
ACTION: Notice; 30-day notice of
information collections under review:
Various contract related forms and
Regulation on Agency Protests, OMB
Control Number 1600–0002 and 1600–
0004.
AGENCY:
SUMMARY: The Department of Homeland
Security (DHS) will submit the
following proposed information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995: 1600–0002 and 1600–0004. The
E:\FR\FM\17DEN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 241 (Monday, December 17, 2007)]
[Notices]
[Pages 71419-71420]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24348]
-----------------------------------------------------------------------
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 the 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 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, call
the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on (a) whether the agency needs to collect the
proposed information to properly perform its functions and whether the
information has any practical utility; (b) whether the agency's
estimate of the burden of the proposed collection of information is
accurate; (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 for respondents (e.g., by using automated
collection techniques or other forms of information technology).
Proposed Project: Ryan White HIV/AIDS Program Part F Dental Services
Report (OMB No. 0915-0151)--Extension
The Dental Reimbursement Program (DRP) and the Community Based
Dental Partnership Program under Part F of the Ryan White HIV/AIDS
Program offer funding to accredited dental education programs to
support the provision of
[[Page 71420]]
oral health services for HIV-positive individuals. Institutions
eligible for these programs are accredited schools of dentistry, post-
doctoral dental education programs and dental hygiene programs.
The DRP Application is the Dental Services Report that schools and
programs use to apply for funding of non-reimbursed costs incurred in
providing oral health care to patients with HIV, or to report annual
program data. Awards are authorized under section 2692(b) of the Public
Health Service Act (42 U.S.C. Sec. 300ff-111(b)). The Dental Services
Report collects data in four different areas: program information,
patient demographics and services, funding, and training. It also
requests applicants to provide narrative descriptions of their services
and facilities, as well as their links and collaboration with
community-based providers of oral health services.
The primary purpose of collecting this information annually is to
verify eligibility and determine reimbursement amounts for DRP
applicants, as well as to document the program accomplishments of
Community-Based Dental Partnership Program grant recipients. This
information also allows HRSA to learn about (1) the extent of the
involvement of dental schools and programs in treating patients with
HIV, (2) the number and characteristics of clients who receive HIV/AIDS
program-supported oral health services, (3) the types and frequency of
the provision of these services, (4) the non-reimbursed costs of oral
health care provided to patients with HIV, and (5) the scope of grant
recipients' community-based collaborations and training of providers.
In addition to meeting the goal of accountability to Congress, clients,
advocacy groups, and the general public, information collected in the
Dental Services Report is critical for HRSA, State and local grantees,
and individual providers, to help assess the status of existing HIV-
related health service delivery systems.
The reporting burden for reviewing the Dental Services Report
Instructions and completing the Report is estimated as:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Services Report............................................. 80 1 80 20 1600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, PhD, HRSA Reports Clearance
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of this
notice.
Dated: December 11, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
[FR Doc. E7-24348 Filed 12-14-07; 8:45 am]
BILLING CODE 4165-15-P
