Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors; Public Workshop, 51041-51042 [2011-20861]
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Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices
The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, IRB inspections,
electronic record requirements, and
investigator initiated research. Topics
for discussion include the following: (1)
What FDA Expects in a Pharmaceutical
Clinical Trial; (2) Adverse Event
Reporting—Science, Regulation, Error,
and Safety; (3) Part 11 Compliance—
Electronic Signatures; (4) Informed
Consent Regulations; (5) IRB
Regulations and FDA Inspections; (6)
Keeping Informed and Working
Together; (7) FDA Conduct of Clinical
Investigator Inspections; (8) Meetings
With FDA: Why, When, and How; (9)
Investigator Initiated Research; (10)
Medical Device Aspects of Clinical
Research; (11) Working With FDA’s
Center for Biologics Evaluation and
Research; (12) The Inspection is Over—
What Happens Next? Possible FDA
Compliance Actions; (13) Ethical Issues
in Subject Enrollment; (14) Medical
Device Aspects of Clinical Research);
(15) Are We There Yet? An Overview of
the FDA GCP Program.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393) which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The public workshop also is
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Pub. L. 104–121) as outreach
activities by Government Agencies to
small businesses.
SUPPLEMENTARY INFORMATION:
Emcdonald on DSK2BSOYB1PROD with NOTICES
Dated: August 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20858 Filed 8–16–11; 8:45 am]
BILLING CODE 4160–01–P
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18:13 Aug 16, 2011
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Hemoglobin Standards and
Maintaining Adequate Iron Stores in
Blood Donors; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Hemoglobin Standards and
Maintaining Adequate Iron Stores in
Blood Donors.’’ The purpose of this
public workshop is to discuss blood
donor hemoglobin and hematocrit
qualification standards in the United
States, its impact on donor safety and
blood availability, and potential
measures to maintain adequate iron
stores in blood donors. The public
workshop has been planned in
partnership with the Department of
Health and Human Services (HHS)
Office of the Assistant Secretary for
Health, the National Heart, Lung and
Blood Institute, America’s Blood
Centers, AABB, and the Plasma Protein
Therapeutics Association. This public
workshop will include presentations
and panel discussions by experts
knowledgeable in the field from
academic institutions, government
agencies, and industry.
Dates and Times: The public
workshop will be held on November 8,
2011, from 8 a.m. to 5:30 p.m. and
November 9, 2011, from 8 a.m. to 3 p.m.
Location: The public workshop will
be held at the Natcher Conference
Center, Main Auditorium, Building 45,
National Institutes of Health, 45 Center
Dr., Bethesda, MD 20892.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or email your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to Rhonda
Dawson (see Contact Person) by October
14, 2011. There is no registration fee for
the public workshop. Early registration
is recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact
PO 00000
Frm 00051
Fmt 4703
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51041
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION:
Under FDA’s current regulations,
allogeneic blood donors must have a
hemoglobin level of no less than 12.5
grams of hemoglobin per 100 milliliters
of blood or a hematocrit value of 38
percent prior to donation (21 CFR
640.3(b)(3) and 640.63(c)(3)).
Hemoglobin and hematocrit
measurements are typically obtained
from a small sample of blood drawn
from a finger or vein. New technologies
that potentially allow for less invasive,
faster, and more convenient methods of
measuring blood donor hemoglobin and
hematocrit levels are being studied. A
low donor hemoglobin and hematocrit
level is the most common reason that
prospective blood donors, particularly
women, are deferred.
Allogeneic donors of a unit of red
blood cells generally may not donate
more than once in an 8 week period to
ensure recovery of their red blood cells
and iron stores (21 CFR 640.3).
Nonetheless, some donors, especially
repeat and premenopausal female
donors, can develop iron deficiency,
with or without anemia, from blood
donation. Improved understanding of
iron loss in blood donors may help
reduce donor deferrals due to low
hemoglobin and hematocrit levels and
reduce iron deficiency that can result
from blood donation. Different strategies
to minimize iron deficiency in blood
donors (e.g., testing for iron stores,
adjusting the donation interval, or
providing iron replacement) have been
explored in the past. Changes in
qualifying hemoglobin levels have been
discussed in various forums for both
men and women to bring these levels
into closer concordance with population
norms. However, the potential risks and
benefits of these strategies require
further discussion.
This public workshop will serve as a
forum for discussion of hemoglobin and
hematocrit donation standards, current
methods for hemoglobin measurement,
iron loss and iron measurement
methods in blood donors, and strategies
to maintain adequate donor iron stores.
The first day of the public workshop
will include presentations and panel
discussions on the following topics: (1)
Hemoglobin standards for blood donors
in the United States; (2) studies of
hemoglobin distribution and deferral
patterns in blood donors; and (3)
measurement of hemoglobin and
hematocrit and iron levels in blood
donors. The second day of the public
workshop will include a discussion of
the following topics: (1) Iron
E:\FR\FM\17AUN1.SGM
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51042
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices
metabolism, iron stores and iron
deficiency in blood donors; and (2)
potential methods to maintain adequate
iron stores in blood donors, including
adjustment of the interdonation interval,
iron measurement and iron
replacement.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible on the Internet at: https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/WorkshopsMeetings
Conferences/TranscriptsMinutes/
default.htm. Transcripts of the public
workshop may also be requested in
writing from the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857.
Dated: August 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20861 Filed 8–16–11; 8:45 am]
BILLING CODE 4160–01–P
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, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Number of
respondents
Form
Proposed Project: Health Education
Assistance Loan (HEAL) Program:
Lender’s Application for Insurance
Claim Form and Request for Collection
Assistance Form (OMB No. 0915–
0036)—Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Responses per
respondent
The clearance request is for an
extension of two forms that are
currently approved by OMB. HEAL
lenders use the Lenders Application for
Insurance Claim to request payment
from the Federal Government for
federally insured loans lost due to
borrowers’ death, disability, bankruptcy,
or default. The Request for Collection
Assistance form is used by HEAL
lenders to request federal assistance
with the collection of delinquent
payments from HEAL borrowers. The
annual estimate of burden is as follows:
Total responses
Hours per
response
Total burden
hours
Lender’s Application for Insurance Claim
Form 510 ......................................................
Request for Collection Assistance Form 513 ..
13
13
28
445
364
5,785
0.50
0.17
182
983
Total Burden .............................................
26
............................
............................
............................
1,165
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email 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: August 11, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–20999 Filed 8–16–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Emcdonald on DSK2BSOYB1PROD with NOTICES
National Institutes of Health
Proposed Collection; Comment
Request; National Institutes of Health
Construction Grants
In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for public comment on proposed data
SUMMARY:
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collection projects, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: National
Institutes of Health Construction Grants
42 CFR Part 52b (Final Rule). Type of
Information Collection Request:
Extension of OMB Control No. 0925–
0424, expiration date 10/31/2011. Need
and Use of the Information Collection:
This request is for OMB review and
approval of a renewal for the
information collection and
recordkeeping requirements contained
in the regulation codified at 42 CFR part
52b. The purpose of the regulation is to
govern the awarding and administration
of grants awarded by NIH and its
components for construction of new
buildings and the alteration, renovation,
remodeling, improvement, expansion,
and repair of existing buildings,
including the provision of equipment
necessary to make the buildings (or
applicable part of the buildings) suitable
for the purpose for which it was
constructed. In terms of reporting
PO 00000
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requirements: Section 52b.9(b) of the
regulation requires the transferor of a
facility which is sold or transferred, or
owner of a facility, the use of which has
changed, to provide written notice of
the sale, transfer or change within 30
days. Section 52b.10(f) requires a
grantee to submit an approved copy of
the construction schedule prior to the
start of construction. Section 52b.10(g)
requires a grantee to provide daily
construction logs and monthly status
reports upon request at the job site.
Section 52b.11(b) requires applicants for
a project involving the acquisition of
existing facilities to provide the
estimated cost of the project, cost of the
acquisition of existing facilities, and
cost of remodeling, renovating, or
altering facilities to serve the purposes
for which they are acquired. In terms of
recordkeeping requirements: Section
52b.10(g) requires grantees to maintain
daily construction logs and monthly
status reports at the job site. Frequency
of Response: On occasion. Affected
Public: Non-profit organizations and
Federal agencies. Type of respondents:
Grantees. The estimated respondent
burden is as follows:
E:\FR\FM\17AUN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51041-51042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20861]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Hemoglobin Standards and Maintaining Adequate Iron Stores in
Blood Donors; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Hemoglobin Standards and Maintaining Adequate Iron
Stores in Blood Donors.'' The purpose of this public workshop is to
discuss blood donor hemoglobin and hematocrit qualification standards
in the United States, its impact on donor safety and blood
availability, and potential measures to maintain adequate iron stores
in blood donors. The public workshop has been planned in partnership
with the Department of Health and Human Services (HHS) Office of the
Assistant Secretary for Health, the National Heart, Lung and Blood
Institute, America's Blood Centers, AABB, and the Plasma Protein
Therapeutics Association. This public workshop will include
presentations and panel discussions by experts knowledgeable in the
field from academic institutions, government agencies, and industry.
Dates and Times: The public workshop will be held on November 8,
2011, from 8 a.m. to 5:30 p.m. and November 9, 2011, from 8 a.m. to 3
p.m.
Location: The public workshop will be held at the Natcher
Conference Center, Main Auditorium, Building 45, National Institutes of
Health, 45 Center Dr., Bethesda, MD 20892.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or email your registration information
(including name, title, firm name, address, telephone and fax numbers)
to Rhonda Dawson (see Contact Person) by October 14, 2011. There is no
registration fee for the public workshop. Early registration is
recommended because seating is limited. Registration on the day of the
public workshop will be provided on a space available basis beginning
at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION:
Under FDA's current regulations, allogeneic blood donors must have
a hemoglobin level of no less than 12.5 grams of hemoglobin per 100
milliliters of blood or a hematocrit value of 38 percent prior to
donation (21 CFR 640.3(b)(3) and 640.63(c)(3)). Hemoglobin and
hematocrit measurements are typically obtained from a small sample of
blood drawn from a finger or vein. New technologies that potentially
allow for less invasive, faster, and more convenient methods of
measuring blood donor hemoglobin and hematocrit levels are being
studied. A low donor hemoglobin and hematocrit level is the most common
reason that prospective blood donors, particularly women, are deferred.
Allogeneic donors of a unit of red blood cells generally may not
donate more than once in an 8 week period to ensure recovery of their
red blood cells and iron stores (21 CFR 640.3). Nonetheless, some
donors, especially repeat and premenopausal female donors, can develop
iron deficiency, with or without anemia, from blood donation. Improved
understanding of iron loss in blood donors may help reduce donor
deferrals due to low hemoglobin and hematocrit levels and reduce iron
deficiency that can result from blood donation. Different strategies to
minimize iron deficiency in blood donors (e.g., testing for iron
stores, adjusting the donation interval, or providing iron replacement)
have been explored in the past. Changes in qualifying hemoglobin levels
have been discussed in various forums for both men and women to bring
these levels into closer concordance with population norms. However,
the potential risks and benefits of these strategies require further
discussion.
This public workshop will serve as a forum for discussion of
hemoglobin and hematocrit donation standards, current methods for
hemoglobin measurement, iron loss and iron measurement methods in blood
donors, and strategies to maintain adequate donor iron stores. The
first day of the public workshop will include presentations and panel
discussions on the following topics: (1) Hemoglobin standards for blood
donors in the United States; (2) studies of hemoglobin distribution and
deferral patterns in blood donors; and (3) measurement of hemoglobin
and hematocrit and iron levels in blood donors. The second day of the
public workshop will include a discussion of the following topics: (1)
Iron
[[Page 51042]]
metabolism, iron stores and iron deficiency in blood donors; and (2)
potential methods to maintain adequate iron stores in blood donors,
including adjustment of the interdonation interval, iron measurement
and iron replacement.
Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
on the Internet at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated: August 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20861 Filed 8-16-11; 8:45 am]
BILLING CODE 4160-01-P
