Establishing a Docket for the Development of Plasma Standards Public Workshop; Notice, 91-92 [04-28655]
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Federal Register / Vol. 70, No. 1 / Monday, January 3, 2005 / Notices
Dated: December 23, 2004.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 04–28661 Filed 12–30–04; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
[Document Identifier: CMS–10112, CMS–R–
218]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Disease Control and
Prevention
AGENCY:
[Funding Opportunity Number: CE05–029]
Dissemination Research on Fall
Prevention: Development and Testing
of an Exercise Program Package To
Prevent Older Adult Falls; Notice of
Availability of Funds—Amendment
A notice announcing the availability
of fiscal year (FY) 2005 funds for
cooperative agreements to conduct a
research program on translating an
exercise intervention that rigorous
research has shown is effective in
reducing falls among older adults into a
program; testing implementation of the
program in a community setting; and
conducting dissemination research
focusing on reach, uptake, feasibility,
fidelity of the implementation, and
acceptability was published in the
Federal Register on November 8, 2004,
Vol. 69, No. 215, pages 64762–64769.
The notice is amended as follows to
remove the requirement for submission
of Letters of Intent (LOI):
On page 64764, column 3, section
III.3. Other, Special Requirements, in
the second bullet change the first
sentence to read ‘‘In order to plan the
application review more effectively and
efficiently, CDC requests that you
submit a Letter of Intent (LOI) to apply
for this program.’’
On page 64765, column 3, section
IV.3. Submission Dates and Times,
remove the one-sentence paragraph
under Letter of Intent (LOI): December
8, 2004.
Dated: December 23, 2004.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 04–28660 Filed 12–30–04; 8:45 am]
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Centers for Medicare & Medicaid
Services
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1.Type of Information Collection
Request: New collection; Title of
Information Collection: Phone Surveys
of Product/Service for Medicare
Payment Validation and Supporting
Regulations in 42 CFR 405.502; Form
No.: CMS–10112 (OMB# 0938–NEW);
Use: This collection will be used to
identify specific Medicare Part B
products/services provided to Medicare
beneficiaries and the costs associated
with the provision of those products/
services. The information collected will
be used to validate the Medicare
payment amounts for those products/
services and institute revisions of
payment amounts where necessary. The
respondents will be the companies that
have provided the product/service
under review to Medicare beneficiaries.;
Frequency: On occasion; Affected
Public: Business or other for-profit;
Number of Respondents: 2,000; Total
Annual Responses: 2,000; Total Annual
Hours: 16,000.
2.Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: ICRS Contained
in 45 CFR Part 162; HIPAA Standards
for Electronic Transactions; Use: This
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submission contains information
collection requirements in HCFA–0149–
F, CMS–0003–P, CMS–0005–P, and
CMS–003/005–F. This collection
establishes standards for electronic
transactions and for code sets to be used
in those transactions. The collection
standardizes the approximately 400
formats of electronic health care claims
used in the United States. The use of
these standards significantly reduces the
administrative burden associated with
paper documents, lowers operating
costs, and improves data quality for
health care providers and health plans;
Form Number: CMS–R–218 (OMB#
0938–0866); Frequency: On occasion;
Affected Public: Business or other forprofit; Number of Respondents: 3.4
million; Total Annual Responses: 3.4
million; Total Annual Hours: 1 hour.
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/
regulations/pra/, or e-mail your request,
including your address, phone number,
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326. Written comments and
recommendations for the proposed
information collections must be mailed
within 30 days of this notice directly to
the OMB desk officer: OMB Human
Resources and Housing Branch,
Attention: Christopher Martin, New
Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: December 23, 2004.
John P. Burke, III,
CMS Paperwork Reduction Act Reports
Clearance Officer, Office of Strategic
Operations and Regulatory Affairs,
Regulations Development Group.
[FR Doc. 04–28649 Filed 12–30–04; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0539]
Establishing a Docket for the
Development of Plasma Standards
Public Workshop; Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
opening of a docket to receive
information and comments on the
August 31 and September 1, 2004,
E:\FR\FM\03JAN1.SGM
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92
Federal Register / Vol. 70, No. 1 / Monday, January 3, 2005 / Notices
public workshop entitled ‘‘Development
of Plasma Standards’’ (the workshop).
We are opening the docket to gather
additional information from interested
parties on the subjects of plasma
collection, freezing, and storage, and for
interested parties to provide comments
on the presentations and discussions
that took place during the workshop.
DATES: Submit written or electronic
comments on the workshop, related
regulatory and scientific issues, and
comments on information submitted to
the docket by other interested parties by
July 5, 2004.
ADDRESSES: Submit written comments
and information regarding the workshop
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852–1448.
Submit electronic comments or
information to https://www.fda.gov/
dockets/ecomments. See the
SUPPLEMENTARY INFORMATION section for
electronic and other access to the slide
presentations and transcripts from the
workshop.
We have established this docket to
encourage interested parties to continue
to provide information about suggested
plasma standards, comments on the
workshop, and comments on
information submitted to the docket by
other interested parties. We also request
that those who have already submitted
written comments and information to
FDA resubmit the same comments to the
docket to ensure their adequate
consideration since this information
was not previously submitted to the
docket. This notice will also be posted
at https://www.fda.gov/cber/minutes/
workshop-min.htm.
Comments submitted to the docket
will assist us in determining the need
for and feasibility of establishing new
standards for currently licensed plasma
products, including time to freezing,
freezing and storage temperatures, and
shipping temperatures, among other
issues. We may also consider this
information in preparing any future
additional standards for recovered
plasma.
FOR FURTHER INFORMATION CONTACT:
II. Comments
Stephen M. Ripley, 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:
I. Background
In the Federal Register of August 9,
2004 (69 FR 48250), we published a
notice to announce a public workshop
entitled ‘‘Development of Plasma
Standards.’’ On August 31 and
September 1, 2004, we held the
workshop to address regulatory and
scientific issues about currently
licensed plasma products and
unlicensed recovered plasma that is
fractionated into both injectable and
non-injectable products. The workshop
covered a broad range of topics. A major
objective of the workshop was to assist
FDA in the development of plasma
standards that would address concerns
encountered over the years with regard
to the preparation, storage, shipment,
and use of plasma for both transfusion
and the manufacture of plasma derived
blood products such as Factor VIII and
Immune Globulin Intravenous. Another
objective was to gather information on
current industry practices that are in
place for the manufacture of plasma. At
the end of the workshop, we invited
written comments from workshop
participants to gather additional public
information on the subject of plasma
freezing and storage.
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Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the workshop.
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 brackets in the
heading of this document. A copy of
this notice, the slide presentations and
transcripts from the workshop, 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.
III. Electronic Access
Persons with access to the Internet
may obtain the slide presentations at
https://www.fda.gov/cber/
summaries.htm and the transcripts of
the workshop at https://www.fda.gov/
cber/minutes/workshop-min.htm.
Dated: December 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04–28655 Filed 12–30–04; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D–0059 (formerly 01D–
0059)]
Guidance for Industry on Submitting
Separate Marketing Applications and
Clinical Data for Purposes of
Assessing User Fees; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Submitting Separate Marketing
Applications and Clinical Data for
Purposes of Assessing User Fees.’’ The
guidance describes the agency’s current
policy on what should be contained in
separate marketing applications and
what should be combined into one
application for purposes of assessing
user fees and a definition of ‘‘clinical
data’’ for user fee purposes.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, or to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
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 https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Center for Drug
Evaluation and Research (HFD–7),
Food and Drug Administration,
5600 Fishers Lane, or Rockville, MD
20857, 301–594–2041, FAX: 301–
827–5562, or
Carla A. Vincent, Center for Biologics
Evaluation and Research (HFM–
110), 1401 Rockville Pike,
Rockville, MD 20852, 301–827–
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]]>Agencies
[Federal Register Volume 70, Number 1 (Monday, January 3, 2005)]
[Notices]
[Pages 91-92]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-28655]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0539]
Establishing a Docket for the Development of Plasma Standards
Public Workshop; Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a docket to receive information and comments on the August
31 and September 1, 2004,
[[Page 92]]
public workshop entitled ``Development of Plasma Standards'' (the
workshop). We are opening the docket to gather additional information
from interested parties on the subjects of plasma collection, freezing,
and storage, and for interested parties to provide comments on the
presentations and discussions that took place during the workshop.
DATES: Submit written or electronic comments on the workshop, related
regulatory and scientific issues, and comments on information submitted
to the docket by other interested parties by July 5, 2004.
ADDRESSES: Submit written comments and information regarding the
workshop to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852-1448.
Submit electronic comments or information to https://www.fda.gov/
dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for
electronic and other access to the slide presentations and transcripts
from the workshop.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, 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:
I. Background
In the Federal Register of August 9, 2004 (69 FR 48250), we
published a notice to announce a public workshop entitled ``Development
of Plasma Standards.'' On August 31 and September 1, 2004, we held the
workshop to address regulatory and scientific issues about currently
licensed plasma products and unlicensed recovered plasma that is
fractionated into both injectable and non-injectable products. The
workshop covered a broad range of topics. A major objective of the
workshop was to assist FDA in the development of plasma standards that
would address concerns encountered over the years with regard to the
preparation, storage, shipment, and use of plasma for both transfusion
and the manufacture of plasma derived blood products such as Factor
VIII and Immune Globulin Intravenous. Another objective was to gather
information on current industry practices that are in place for the
manufacture of plasma. At the end of the workshop, we invited written
comments from workshop participants to gather additional public
information on the subject of plasma freezing and storage.
We have established this docket to encourage interested parties to
continue to provide information about suggested plasma standards,
comments on the workshop, and comments on information submitted to the
docket by other interested parties. We also request that those who have
already submitted written comments and information to FDA resubmit the
same comments to the docket to ensure their adequate consideration
since this information was not previously submitted to the docket. This
notice will also be posted at https://www.fda.gov/cber/minutes/workshop-
min.htm.
Comments submitted to the docket will assist us in determining the
need for and feasibility of establishing new standards for currently
licensed plasma products, including time to freezing, freezing and
storage temperatures, and shipping temperatures, among other issues. We
may also consider this information in preparing any future additional
standards for recovered plasma.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the workshop.
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 brackets
in the heading of this document. A copy of this notice, the slide
presentations and transcripts from the workshop, 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.
III. Electronic Access
Persons with access to the Internet may obtain the slide
presentations at https://www.fda.gov/cber/summaries.htm and the
transcripts of the workshop at https://www.fda.gov/cber/minutes/
workshop-min.htm.
Dated: December 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-28655 Filed 12-30-04; 8:45 am]
BILLING CODE 4160-01-S
