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From: TSS ()
Subject: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule and Notice (TSEs)
Date: May 24, 2005 at 2:29 pm PST


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Tuesday, May 24, 2005 4:26 PM
Subject: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule and Notice


##################### Bovine Spongiform Encephalopathy #####################

Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Final Rule and Notice

(SEE TSEs...TSS)

[Federal Register: May 25, 2004 (Volume 69, Number 101)]
[Rules and Regulations]
[Page 29785-29834]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my04-11]


[[Page 29785]]

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Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 210, 211, 820, and 1271

Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Final Rule and Notice


[[Page 29786]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 210, 211, 820, and 1271

[Docket No. 1997N-0484S]
[RIN 0910-AB27]


Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is requiring human
cell, tissue, and cellular and tissue-based product (HCT[sol]P)
establishments to screen and test cell and tissue donors for risk
factors for, and clinical evidence of, relevant communicable disease
agents and diseases. The agency is amending the current good
manufacturing practice (CGMP) and quality system (QS) regulations that
apply to HCT[sol]Ps regulated as drugs, medical devices, and/or
biological products to clarify the role of the new donor-eligibility
regulations in relation to existing CGMP regulations. By preventing the
transmission of communicable disease by the wide spectrum of HCT[sol]Ps
that are marketed now or may be marketed in the future, the agency's
action will improve protection of the public health and increase public
confidence in new technologies.

DATES: This rule is effective May 25, 2005. This rule is applicable to
cells and tissues recovered on or after May 25, 2005.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, 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:

Table of Contents

I. Introduction
A. Background
B. Legal Authority
II. Highlights of the Final Rule
A. Plain Language
B. New Terminology and Definitions
C. Other Highlights
III. Comments on the Proposed Rule and FDA's Responses
A. General
B. Amendments to 21 CFR Parts 210, 211, and 820
C. Definitions (Sec. 1271.3)
D. Part 1271, Subpart C--Donor-Eligibility
E. Economic Impacts
IV. Analysis of Economic Impacts
A. Objectives and Basis of the Proposed Action
B. The Type and Number of Entities Affected
C. Nature of Impacts
D. Benefits of the Final Rule
E. Small Entity Impacts and Analysis of Alternatives
V. Environmental Impact
VI. Federalism Assessment
VII. The Paperwork Reduction Act of 1995
VIII. References

I. Introduction

This final rule is part of a comprehensive new system of regulation
for HCT[sol]Ps. The goal of the new approach is to improve protection
of the public health without imposing unnecessary restrictions on
research, development, or the availability of new products.
Consolidating the regulation of HCT[sol]Ps into one regulatory program
is expected to lead to increased consistency and greater efficiency.
Together, these planned improvements will increase the safety of
HCT[sol]Ps, and public confidence in their safety. We intend to make
the good tissue practice final rule, which has not yet published but
which FDA intends to issue soon, effective 1 year after publication of
this rule. Once both this rule and the good tissue practice regulations
are in effect, FDA's comprehensive regulatory framework will be
complete.

A. Background

In 1997, FDA proposed a new approach to the regulation of
HCT[sol]Ps (62 FR 9721, March 4, 1997). (The term ``HCT[sol]P'' is
defined at Sec. 1271.3(d) (21 CFR 1271.3(d).) To improve the
regulation of HCT[sol]Ps, we announced our intention to establish a
comprehensive regulatory program for HCT[sol]Ps, contained in part 1271
(21 CFR part 1271). In accordance with the tiered, risk-based approach
that we proposed, some HCT[sol]Ps would be regulated only under these
new regulations, while others would also be regulated as drugs,
devices, and/or biological products.
To implement the proposed approach, we issued three proposed rules:
Establishment Registration and Listing for Manufacturers
of Human Cellular and Tissue-Based Products (the registration proposed
rule) (63 FR 26744, May 14, 1998);
Suitability Determination for Donors of Human Cellular and
Tissue-Based Products (the donor-suitability proposed rule) (64 FR
52696, September 30, 1999); and
Current Good Tissue Practice for Manufacturers of Human
Cellular and Tissue-Based Products; Inspection and Enforcement (the
CGTP proposed rule) (66 FR 1508, January 8, 2001).
We published a final rule entitled ``Human Cells, Tissues, and
Cellular and Tissue-Based Products; Establishment Registration and
Listing,'' in the Federal Register on January 19, 2001 (the
registration final rule) (66 FR 5447). The registration final rule put
into place general provisions pertaining to the scope and applicability
of part 1271. These provisions are contained in subpart A of part 1271,
along with a section that contains definitions applicable to all of
part 1271 (Sec. 1271.3). The registration final rule requires cell and
tissue establishments to register with us and submit a list of their
HCT[sol]Ps; the procedures for registration and listing are contained
in subpart B of part 1271.
Some sections of the registration final rule became effective on
April 4, 2001. Under those provisions, we now receive registration and
listing information from establishments that engage in the recovery,
screening, testing, processing, storage, or distribution of human
tissue intended for transplantation (as described in Sec.
1271.3(d)(1)). The effective date for the remaining sections was
January 21, 2003, by which time we expected to have completed
rulemaking for all of part 1271 (66 FR 5447 at 5448). At that time, the
registration and listing requirements would have become effective for
all other HCT[sol]Ps (as described in Sec. 1271.3(d)(2)). However, we
recognized that unanticipated delays in completing the rulemaking for
the remainder of part 1271 could occur, and we noted that, should the
rulemaking proceedings be delayed past the 2-year timeframe, we would
consider whether to maintain the 2-year effective date for the
HCT[sol]Ps described in Sec. 1271.3(d)(2) or whether to extend that
date for some or all of these HCT[sol]Ps (66 FR 5447 at 5449). Since
the rulemaking proceedings were delayed past the original 2-year
effective date of January 21, 2003, we delayed the effective date of
Sec. 1271.3(d)(2) until January 21, 2004 (68 FR 2690, January 21,
2003). After the definition became final on January 21, 2004, we issued
an interim final rule excepting human dura mater and human heart valve
allografts from the scope of the definition of ``human cells, tissues,
or cellular or tissue-based products (HCT[sol]Ps)'' (69 FR 3823,
January 27, 2004). We took this action to assure that these products,
which were subject to the Federal Food, Drug, and Cosmetic Act (the
act) and therefore regulated under the current good

[[Page 29787]]

manufacturing practice regulations set out in the quality system
regulations in part 820 (21 CFR part 820), were not released from the
scope of those regulations before a more comprehensive regulatory
framework applicable to HCT[sol]Ps, including donor eligibility
requirements, good tissue practice regulations, and appropriate
enforcement provisions, is fully in place. When that comprehensive
framework is in place, we intend that human dura mater and human heart
valve allografts will be subject to it. We intend to revoke the interim
final rule at that time.
We are now making final the donor-suitability proposed rule that
was proposed on September 30, 1999. (For reasons discussed in comment
26 of this document, we refer in this final rule to donor
``eligibility'' rather than ``suitability.'') The comment period for
that proposed rule closed on December 29, 1999. On April 18, 2000, we
reopened the comment period for an additional 90 days. We took this
step in response to requests for an extension of the comment period as
well as to provide sufficient time for State officials to participate
in the rulemaking (65 FR 20774, April 18, 2000).
Because of their nature as derivatives of the human body,
HCT[sol]Ps pose a risk of transmitting communicable diseases. For this
reason, this final rule requires that most cell and tissue donors be
tested and screened for evidence of relevant communicable disease
infection. It also contains other related requirements (e.g., on
records, quarantine, storage, and labeling). These donor-eligibility
requirements, which locate in subpart C of part 1271, are part of the
core requirements applicable both to HCT[sol]Ps regulated solely under
these regulations and section 361 (the 361 HCT[sol]Ps) of the Public
Health Service Act (the PHS Act) and to those HCT[sol]Ps also subject
to regulation as drugs, devices, and/or biological products. As part of
this rulemaking, we are also amending the drug CGMP regulations and the
device QS regulations to clarify the role of the donor-eligibility
requirements in the manufacture of HCT[sol]Ps subject to regulation as
drugs, devices, and/or biological products.
Since the publication of the donor-suitability proposed rule, we
have continued to obtain current and accurate information on the risks
of communicable-disease transmission by HCT[sol]Ps and the most
appropriate testing and screening measures. To this end, we have met
with FDA's Transmissible Spongiform Encephalopathies Advisory Committee
(TSEAC) (January 18 to 19, 2001, and June 26 to 27, 2002); the Blood
Products Advisory Committee (BPAC) (December 13 to 14, 2001, and March
14 to 15, 2002); and the Centers for Disease Control and Prevention
(CDC) (June 26 to 27, 2000). We have placed information on these
meetings in the docket for this rulemaking.
We have used the information obtained at those meetings to develop
a draft guidance document on determining donor eligibility entitled
``Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products'' (the donor-eligibility draft
guidance). Elsewhere in this issue of the Federal Register, we announce
the availability of that draft guidance, and solicit comments on its
contents. We have also developed draft guidance on screening for
Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease
(vCJD) entitled ``Guidance for Industry: Preventive Measures to Reduce
the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD)
and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT[sol]Ps)'' (the CJD draft
guidance) (67 FR 42789, June 25, 2002). We intend to combine the donor-
eligibility draft guidance with the CJD draft guidance, and to issue a
single final guidance document.

B. Legal Authority

We are issuing these new regulations under the authority of section
361 of the PHS Act (42 U.S.C. 264). Under that section, by delegation
from the Surgeon General and the Secretary of Health and Human
Services, FDA may make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
the States or from foreign countries into the States. Intrastate
transactions affecting communicable disease transmission may also be
regulated under section 361 of the PHS Act. (See Louisiana v. Mathews,
427 F. supp. 174, 176 (E.D. La. 1977).)
It is especially important to recognize that HCT[sol]P
manufacturing inevitably has interstate effects. HCT[sol]Ps recovered
in one State may be sent to another for processing, then shipped for
use throughout the United States, or beyond. FDA has been involved in
many recalls where HCT[sol]Ps processed in a single establishment have
been distributed in many States.
Section 361 of the PHS Act authorizes FDA to issue regulations
necessary to prevent the introduction, transmission, or spread of
communicable diseases. Communicable diseases include, but are not
limited to, those transmitted by viruses, bacteria, fungi, parasites,
and transmissible spongiform encephalopathy agents.
Certain diseases are transmissible through the implantation,
transplantation, infusion, or transfer of HCT[sol]Ps derived from
donors infected with those diseases. To prevent the introduction,
transmission, or spread of such diseases, we consider it necessary to
take appropriate measures to prevent the use of cells or tissues from
infected donors. Thus, these regulations require that, before the use
of most HCT[sol]Ps, the cell or tissue donor must be determined to be
eligible to donate, based on the results of screening and testing for
relevant communicable diseases. In most cases, a donor who tests
reactive for a particular disease, or who possesses clinical evidence
of or risk factors for such a disease, would be considered ineligible,
and cells and tissues from that donor would not ordinarily be used.
In addition to regulations governing the testing and screening of
donors for relevant communicable disease and quarantine and storage of
HCT[sol]Ps, FDA has also determined that regulations requiring
establishments to maintain certain records related to HCT[sol]Ps and to
establish standard operating procedures are necessary to prevent the
introduction, transmission, or spread interstate of communicable
disease. A single donor may be the source of a large number of
HCT[sol]Ps. For example, it may be discovered, long after the donation
and transplantations have been completed, that a donor of HCT[sol]Ps
transplanted into a large number of recipients had a relevant
communicable disease. Although it might be too late to prevent the
recipients' infections, it would not be too late to for the recipient
to obtain treatment and take steps to avoid infecting others, such as
close family members. However, unless adequate records were maintained,
and maintained for the period of time throughout which infections may
be identified, it would be impossible to identify the recipients
potentially infected by the donor's HCTPs. This would be a critical
breakdown in the prevention of disease transmission. Accordingly, FDA
determined that the maintenance and retention of records are necessary
to prevent the interstate introduction, transmission, and spread of
communicable disease. Since some diseases, such as transmissible
spongiform encephalopathies (TSEs), appear to have a long latency
period, FDA has determined that a 10-year record retention period is
necessary.
Similarly, it is necessary for establishments to establish,
maintain,

[[Page 29788]]

and follow procedures related to the prevention of communicable
disease. The agency has determined that these provisions are necessary
to ensure that the important protections created by these regulations
are actually effected and are not simply empty promises. Only
manufacturing conducted in accordance with established procedures can
assure that HCT[sol]Ps meet the standards in these rules. If
standardized processes are not developed and used, mistakes,
inevitably, are made. Moreover, review of procedures can be critical to
determining the cause of a disease transmission. Without that analysis,
it would be impossible to prevent a future occurrence, with possibly
fatal consequences.
These regulations are intended to prevent the transmission of
communicable disease through the implantation, transplantation,
infusion, or transfer of HCT[sol]Ps. However, as noted in the
registration and donor-suitability proposed rules, all HCT[sol]Ps pose
some risk of carrying pathogens that could cause disease in health-care
personnel, other handlers of tissue, recipients, and family members or
other contacts of recipients (63 FR 26744 and 64 FR 52696 at 52698).
This broader concern for the spread of communicable disease is
reflected in certain labeling requirements in these regulations and in
the criteria for identifying a relevant communicable disease. We
recognize that regulations exist that are specifically designed to
protect employees who may come in contact with infectious materials
(see 29 CFR 1910.1030, 42 CFR 72.6, and 49 CFR 173.196), and we do not
consider these regulations to be in conflict with those other
regulations currently in effect. However, we have made an effort to be
consistent with the terminology used in these other regulations; e.g.,
``Infectious Substances'' and the Biohazard legend.
Under section 361 of the PHS Act, FDA is authorized to enforce the
regulations it issues to prevent the introduction, transmission, or
spread of communicable diseases interstate through such means as
inspection, disinfection, sanitation, destruction of animals or
articles found to be so infected or contaminated as to be sources of
dangerous infection in human beings, and other measures that may be
necessary. In addition, under section 368(a) of the PHS Act, any person
who violates a regulation prescribed under section 361 of the PHS Act
may be punished by imprisonment for up to 1 year. Individuals may also
be punished for violating such a regulation by a fine of up to $100,000
if death has not resulted from the violation or up to $250,000 if death
has resulted. For organizational defendants, fines range up to $200,000
and $500,000. Individuals and organizations also face possible
alternative fines based on the amount of gain or loss (18 U.S.C. 3559
and 3571(b) through (d)). Federal District Courts also have
jurisdiction to enjoin individuals and organizations from violating
regulations implementing section 361 of the PHS Act. (See Califano v.
Yamasaki, 442 U.S. 682, 704-05 (1979); United States v. Beatrice Foods
Co., 493 F.2d 1259, 1271-72 (8th Cir. 1974), cert. denied, 420 U.S. 961
(1975).) Under sections 501(a)(2)(B) and (h), and 520(f)(1) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351(a)(2)(B)
and (h), and 21 U.S.C. 360j(f)(1)), drugs (including biological
products) and devices (including biological products) are subject to
CGMP requirements designed to ensure, among other things, product
safety (21 U.S.C. 351(a)(2)(B) and (h), and 21 U.S.C. 360j(f)(1)). The
authorities supporting the CGMP and QS regulations are also applicable
when the CGMP and QS regulations apply to an HCT[sol]P regulated as a
drug, biological product, or device. Currently, the CGMP and QS
regulations applicable to HCT[sol]Ps regulated as drugs or devices do
not delineate testing and screening procedures for communicable
diseases. (See parts 210, 211, and 820 (21 CFR parts 210, 211, and
820).) Nevertheless, we consider communicable-disease testing and
screening to be steps in the manufacturing process that are crucial to
the safety of such products. As a result, we are amending the existing
CGMP regulations for drugs in parts 210 and 211 and the QS regulations
for devices in part 820, which include CGMP requirements, to make clear
that the testing and screening provisions of part 1271 subpart C apply
to HCT[sol]Ps regulated as drugs, devices, and/or biological products.
Under Sec. 210.1(c), the manufacturer of an HCT[sol]P regulated as
a drug, including a biological product that is a drug under the act,
must comply with the donor-eligibility procedures in part 1271, subpart
C. Failure to follow the CGMP requirements, including the testing and
screening procedures in part 1271, would make the product adulterated
under the act. In issuing this regulation, FDA is relying on the drug
CGMP authorities (in particular, section 501(a)(2)(B) of the act (21
U.S.C. 351(a)(2)(B)), as well as section 361 of the PHS Act. Under
Sec. 820.1(a)(1), the manufacturer of an HCT[sol]P regulated as a
device, including a biological product that is a device under the act,
must comply with the same procedures.
Section 375 of the PHS Act provides for Federal oversight of the
nation's Organ Procurement and Transplantation Network, and section 379
of the PHS Act authorizes the National Bone Marrow Donor Registry (42
U.S.C. 274c and 274k). The Health Resources and Services Administration
(HRSA) currently administers both of these programs. Given HRSA
oversight in these areas, vascularized human organs (to include
vascularized subparts of human organs) and minimally manipulated bone
marrow (as defined in Sec. 1271.3(d)(2)) for unrelated allogeneic use
are specifically excluded from these final regulations.

II. Highlights of the Final Rule

This final rule requires establishments to make donor-eligibility
determinations for cell and tissue donors, based on donor screening and
testing for relevant communicable disease agents and diseases (Sec.
1271.45). The regulations cover how to screen and test donors
(Sec. Sec. 1271.75, 1271.80, and 1271.85), as well as how to make the
donor-eligibility determination (Sec. 1271.50). The term ``relevant
communicable disease agent or disease'' is defined at Sec. 1271.3(r).
The rule also contains related requirements pertaining to procedures
(Sec. 1271.47); records (Sec. 1271.55); quarantine (Sec. 1271.60);
and storage of HCT[sol]Ps from ineligible donors (Sec. 1271.65). Two
of these provisions describe situations where it is not prohibited to
use an HCT[sol]P from an ineligible donor or a donor who has not yet
been determined eligible (Sec. Sec. 1271.60 and 1271.65). Exceptions
from the requirement for making a donor-eligibility determination
appear in Sec. 1271.90.
The donor-eligibility draft guidance that may be found elsewhere in
this Federal Register is intended to assist establishments in complying
with the requirements of this final rule and contains details that are
not in the regulation. Although not binding, the draft guidance
presents the agency's current thinking on the topics covered. For
example, whereas the regulation requires an establishment to screen
donors for risk factors, the draft guidance specifies what we consider
those risk factors to be. Similarly, the draft guidance contains
recommendations on which tests to use to comply with the testing
requirements in Sec. Sec. 1271.80 and 1271.85. The draft guidance also
identifies several additional disease agents or diseases that we
believe meet the definition of relevant communicable disease agent or

[[Page 29789]]

disease. We welcome comments on the draft guidance. As scientific
knowledge is developed, new tests are introduced, and additional
relevant communicable disease agents and diseases are identified, we
intend to follow the good guidance practices set out in Sec. 10.115 to
modify the donor-eligibility guidance so that it remains current.

A. Plain Language

In the Federal Register of June 10, 1998 (63 FR 31885), the
Presidential Memorandum on Plain Language in Government Writing was
issued. The goal of the plain language initiative is to publish
government documents that are easier to understand.
In response to this initiative, we have written the donor-
eligibility regulation in plain language. We have taken the following
actions:
Written the regulation in question-and-answer format;
Reorganized some regulatory sections for greater clarity;
and
Followed other plain-language conventions, such as using
``must'' instead of ``shall.''
The resulting codified language is easier to read and understand
than the proposed regulation. These editorial changes are for clarity
only and do not change the substance of the requirements.

B. New Terminology and Definitions

In the registration final rule, we discussed our decision to
replace the term ``human cellular or tissue-based products'' with
``human cells, tissues, and cellular and tissue-based products''
(abbreviated HCT[sol]Ps) (66 FR 5447 at 5455). For consistency, we have
made the same change in this final rule.
In response to comments, we have changed the term ``donor
suitability'' to ``donor eligibility.''
In addition, we have made several changes to the definition of
``relevant communicable disease agent or disease'' with respect to
prevalence. We intend the new language to cover both intentional and
unintentional release of infectious agents.
We have also modified the definition of ``directed donor'' and
changed the term to ``directed reproductive donor.''
We have deleted the definitions of ``xenotransplantation'' and
``close contacts.''

C. Other Highlights

This final rule contains other changes from the proposed rule.
These changes are listed as follows:
Provisions in Sec. 1271.47, originally proposed in the
CGTP proposed rule, require that HCT[sol]P establishments establish and
maintain procedures for the steps they perform in determining donor
eligibility, including testing and screening;
The requirement for donor retesting 6 months after
donation now applies only to anonymous semen donors. In addition, you
do not have to obtain a specimen for testing at each donation from a
repeat anonymous donor, so long as you do not release the donation
unless the donor has been retested (at least 6 months post donation).
Directed donations of semen are excepted from the retesting
requirement;
Physical separation between HCT[sol]Ps from ineligible and
eligible donors is no longer required;
We have removed the requirement that a physician must
consent to the use of an HCT[sol]P from an ineligible donor;
You must screen all donors for Treponema pallidum and some
donors for Human T-lymphotropic virus (HTLV) (in addition to testing);
You must screen donors for ``communicable disease risks
associated with xenotransplantation.'' Under the proposed rule, receipt
of a xenotransplantation product would have made a donor ineligible
under all circumstances. Now, receipt of a xenotransplantation product
no longer overrides the special circumstances, listed in Sec.
1271.65(b)(1), under which use of an HCT[sol]P from an ineligible donor
is not prohibited;
We have modified the requirements applicable to testing
for Cytomegalovirus (CMV);
If the donor is one month of age or younger, you must test
a specimen from the birth mother;
The requirements on timing of specimen collection allow 7
days before or after recovery, or for donors of peripheral blood stem
progenitor cells only, up to 30 days before recovery, if specimen
collection at the time of recovery is not feasible; and
Required testing can be performed by a laboratory that has
met requirements equivalent to those imposed by the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), as determined by the Centers for
Medicare and Medicaid Services (CMS).

III. Comments on the Proposed Rule and FDA's Responses

snip...full text at ;


http://www.fda.gov/cber/rules/suitdonor.htm


2005

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Interim Final Rule - 5/24/2005 - (PDF)


a.. Questions and Answers: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Interim Final Rule - 5/24/2005

a.. FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule - 5/25/2004 - (PDF), (Text)

a.. Questions and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance - (Text)
FEDERAL REGISTER Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Final Rule; Technical Amendment - 3/24/2005 - (PDF), (Text)


TSS

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